AphasiaNCT05561400
Combining tDCS and CILT in Non-fluent Aphasia
A study testing tDCS in people with Aphasia and Non-fluent Aphasia, run by University of Minnesota at 1 site in United States.
Trial summary
The long-term goal of this work is to determine if combining a highly intensive, task-specific behavioral language intervention with modulation of the efferent cerebellar-cortical pathway using transcranial direct current stimulation (tDCS) has a positive influence on discourse, verbal fluency and working memory in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Non-fluent Aphasia, Stroke
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over the age of 18 years
- history of stroke
- diagnosed with non-fluent aphasia.
- be able to independently understand simple directions,
- use some speech to communicate,
- have access to reliable transportation (including taxi and/or other transportation services),
- fluent in English.
Who cannot join
- Pregnancy,
- history of seizures,
- any metal implants in the body (excluding dental fillings),
- history of migraines,
- psoriasis or eczema affecting the scalp,
- history of a head injury such as a concussion
- diagnosis of a mental health or neurological condition/disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Cerebellar tDCS and Constraint-induced Language Therapy in Non-fluent Aphasia: a Novel Approach to Target Discourse
The long-term goal of this work is to determine if combining a highly intensive, task-specific behavioral language intervention with modulation of the efferent cerebellar-cortical pathway using transcranial direct current stimulation (tDCS) has a positive influence on discourse, verbal fluency and working memory in individuals with non-fluent aphasia after stroke. And if these changes can be related to neuroplastic change in the cerebellar cortical pathway indirectly measured through neurophysiologic changes using spectral electroencephalogram (EEG). The initial phase includes the proposed pilot study data from which will be used to inform a larger clinical trial. The primary aims of this pilot are to 1) determine the effect of combining cerebellar tDCS with constraint-induced language therapy (CILT) on language as measured by a verbal fluency task and discourse task in a small population and 2) identify the tolerance of the intervention and barriers to participation measured by the adverse events questionnaire that will inform the methodology of a larger study. The secondary aims include estimating the size of the treatment effect on 1) delta percentage in F3, F7 and Fp1 compared to F4, F8, and Fp2 using resting state EEG spectral analysis and coherence, 2) working memory as measured by the score on the n-back test and 3) quality of life as measured by the Stroke Aphasia Quality of Life survey tool. The secondary aims will be used to determine the utility of these measures in a larger clinical trial.
This is a prospective, crossover study, sham-controlled intervention study with two intervention conditions delivered across 6 intervention sessions (3x/week for two weeks) with a 4-week washout in between. Conditions include: 1) sham cerebellar tDCS and 2) real cerebellar tDCS delivered at 2mA across 20 minutes. Each of these will be delivered during CILT intervention with a licensed, certified speech-language pathologist trained in CILT. Once tDCS stimulation has ended, CILT will continue to be delivered for an additional 25 minutes. Assessments of discourse, verbal fluency, working memory and EEG spectral analysis will be conducted at four timepoints, before and after each intervention phase.
Read the detailed description
This is a prospective sham-controlled, cross-over design. Eligible participants must be over the age of 18 years, be > least 6 months post unilateral cortical stroke and diagnosed with mild to moderate non-fluent aphasia. Additional inclusion/exclusionary criteria have been specified in and approved by the IRB. Six to seven participants are expected to be recruited and screened, with the goal to enroll and complete the study with four individuals who will be randomly assigned to receive either sham or real condition first. The two intervention conditions include: 1) andodal tDCS (2mA) to the right posterior-lateral cerebellum and 2) sham tDCS to the right posterior-lateral cerebellum. The participants will receive 20 minutes of tDCS (sham or real) during CILT followed by an additional 25 minutes of CILT alone. Each condition will be administered 3 days per week for two weeks for a total of 6 intervention sessions with a 4-week washout period between.
For tDCS (TCT-Research Version tDCS Stimulator, Hong Kong), two 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting the posterior lateral cerebellum and the cathode will be placed on the right shoulder. The electrode placement will be the same across both conditions. The CILT behavioral intervention will be led by a certified, licensed speech-language pathologist and a graduate student researcher and will follow the guidelines of CILT.
- Conditions
- Aphasia, Non-fluent Aphasia, Stroke, Brain Injuries
- Being tested
- tDCS, Placebo
- Keywords
- transcranial direct current stimulation (tDCS), non-invasive brain stimulation (NIBS), aphasia, constraint-induced language therapy (CILT)
- Medical subject headings
- Aphasia, Aphasia, Broca, Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
5x5 saline-soaked sponge electrodes will be used with the cathode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the anode will be placed on the right shoulder. The electrode placement will be the same across both conditions.
PlaceboOther
sham tDCS to the right cerebellum
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Active comparator | the participant receives real tDCS to the right cerebellum during behavioral intervention (CILT) Receives: Device: tDCS |
| Sham tDCS | Placebo comparator | the participant receives sham tDCS to the right cerebellum during behavioral intervention (CILT) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discourse: Picture Description
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Baseline 1: occurred at Visit 2 (after consent)
Discourse Analysis: Picture Description
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Follow up 1: Visit 9. 2 weeks after Baseline 1
Discourse: Picture Description
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Discourse Analysis: Picture Description
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Baseline 1: occurred at Visit 2
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Follow up 1: Visit 9: 2 weeks after Baseline 1
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1
Discourse Analysis: Story Retell
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Baseline 1: Visit 2
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Follow up 1: Visit 9: 2 weeks after Baseline 1
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1
Discourse Analysis: Procedural
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Verbal Fluency: Semantic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Baseline 1: Visit 2
Verbal Fluency: Semantic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Follow up 1: Visit 9: 2 weeks after Baseline 1
Verbal Fluency: Semantic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Verbal Fluency: Semantic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2
Verbal Fluency: Phonemic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Baseline 1: Visit 2
Verbal Fluency: Phonemic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Follow up 1: Visit 9: 2 weeks after Baseline 1
Verbal Fluency: Phonemic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Verbal Fluency: Phonemic
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Secondary outcomes (8)
Working Memory
To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%. A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Baseline 1: Visit 2
Working Memory
To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%.A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Follow up 1: Visit 9: 2 weeks after Baseline 1
Working Memory
To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%. A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Working Memory
To measure working memory, the participant will complete the 2 n-back test. The score represents the raw score which is calculated as the total possible minus errors, which is called the accuracy score. The higher the score the better. In healthy adults, the average accuracy score is between 50%-75%. A minium accuracy score is 0 and the maximum score is 100%. There are no subscales in this measure.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Stroke Aphasia Quality of Life (SA-QOL)
Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Response scale between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. 3 subscales:
Physical, the total number of questions is 16, minimum score is 16 and the maximum score is 80.
Communication, the total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5 Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Baseline 1: Visit 2
Stroke Aphasia Quality of Life (SA-QOL)
Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Scale is between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. 3 subscales:
Physical, total number of questions is 16, minimum score is 16 and the maximum score is 80.
Communication, total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5. The higher the score reflect better quality of life.
Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Measured: Follow up 1: Visit 9: 2 weeks after Baseline 1
Stroke Aphasia Quality of Life (SA-QOL)
Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Response scale is between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. There are 3 subscales:
Physical, total number of questions is 16, minimum score is 16 and the maximum score is 80.
Communication, the total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5. The higher the score reflect better quality of life.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Stroke Aphasia Quality of Life (SA-QOL)
Stroke Aphasia Quality of Life (SA-QOL) is a participant perception survey. Response scale is between 1 and 5. 1=Total help / couldn't do it at all / strongly agree, 2=a lot of help / a lot of trouble / moderately agree, 3= some help / some trouble / neight agree nor disagree, 4= a little help / a little trouble / moderately disagree or 5= no help needed / no trouble at all / strongly disagree. There are 3 subscales:
Physical, the total number of questions is 16, minimum score is 16 and the maximum score is 80.
Communication, the total number of qustions is 7, minimum score is 7 and maximum score is 35 Psychosocial, the total number of questions is 16, minimum score is 16 and maximum score is 80 Scores from these subscales are totalled and divided by 39 to get the score. Total minimum score is 1 and total maximum score is 5. The higher the score reflect better quality of life.
Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Measured: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start24 Apr 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Sham controlled blinded crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharyl A Samargia-Grivette, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561400
- Sponsor's protocol ID
- SLP-2022-29906
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2022
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Cerebellar tDCS and Constraint-induced Language Therapy in Non-fluent Aphasia: a Novel Approach to Target Discourse
- ClinicalTrials.gov ID
- NCT05561400
- Acronym / sponsor ID
- SLP-2022-29906
- Conditions
- Aphasia, Non-fluent Aphasia, Stroke, Brain Injuries
- Keywords
- transcranial direct current stimulation (tDCS), non-invasive brain stimulation (NIBS), aphasia, constraint-induced language therapy (CILT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of this work is to determine if combining a highly intensive, task-specific behavioral language intervention with modulation of the efferent cerebellar-cortical pathway using transcranial direct current stimulation (tDCS) has a positive influence on discourse, verbal fluency and working memory in individuals with non-fluent aphasia after stroke. And if these changes can be related to neuroplastic change in the cerebellar cortical pathway indirectly measured through neurophysiologic changes using spectral electroencephalogram (EEG). The initial phase includes the proposed pilot study data from which will be used to inform a larger clinical trial. The primary aims of this pilot are to 1) determine the effect of combining cerebellar tDCS with constraint-induced language therapy (CILT) on language as measured by a verbal fluency task and discourse task in a small population and 2) identify the tolerance of the intervention and barriers to participation measured by the adverse events questionnaire that will inform the methodology of a larger study. The secondary aims include estimating the size of the treatment effect on 1) delta percentage in F3, F7 and Fp1 compared to F4, F8, and Fp2 using resting state EEG spectral analysis and coherence, 2) working memory as measured by the score on the n-back test and 3) quality of life as measured by the Stroke Aphasia Quality of Life survey tool. The secondary aims will be used to determine the utility of these measures in a larger clinical trial.
This is a prospective, crossover study, sham-controlled intervention study with two intervention conditions delivered across 6 intervention sessions (3x/week for two weeks) with a 4-week washout in between. Conditions include: 1) sham cerebellar tDCS and 2) real cerebellar tDCS delivered at 2mA across 20 minutes. Each of these will be delivered during CILT intervention with a licensed, certified speech-language pathologist trained in CILT. Once tDCS stimulation has ended, CILT will continue to be delivered for an additional 25 minutes. Assessments of discourse, verbal fluency, working memory and EEG spectral analysis will be conducted at four timepoints, before and after each intervention phase.
Detailed description
This is a prospective sham-controlled, cross-over design. Eligible participants must be over the age of 18 years, be > least 6 months post unilateral cortical stroke and diagnosed with mild to moderate non-fluent aphasia. Additional inclusion/exclusionary criteria have been specified in and approved by the IRB. Six to seven participants are expected to be recruited and screened, with the goal to enroll and complete the study with four individuals who will be randomly assigned to receive either sham or real condition first. The two intervention conditions include: 1) andodal tDCS (2mA) to the right posterior-lateral cerebellum and 2) sham tDCS to the right posterior-lateral cerebellum. The participants will receive 20 minutes of tDCS (sham or real) during CILT followed by an additional 25 minutes of CILT alone. Each condition will be administered 3 days per week for two weeks for a total of 6 intervention sessions with a 4-week washout period between.
For tDCS (TCT-Research Version tDCS Stimulator, Hong Kong), two 5x5 saline-soaked sponge electrodes will be used with the anode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting the posterior lateral cerebellum and the cathode will be placed on the right shoulder. The electrode placement will be the same across both conditions. The CILT behavioral intervention will be led by a certified, licensed speech-language pathologist and a graduate student researcher and will follow the guidelines of CILT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Sham controlled blinded crossover design
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Active comparator | Device: tDCSthe participant receives real tDCS to the right cerebellum during behavioral intervention (CILT) |
| Sham tDCS | Placebo comparator | Other: Placebothe participant receives sham tDCS to the right cerebellum during behavioral intervention (CILT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- over the age of 18 years
- history of stroke
- diagnosed with non-fluent aphasia.
- be able to independently understand simple directions,
- use some speech to communicate,
Key exclusion criteria (7 listed)
- Pregnancy,
- history of seizures,
- any metal implants in the body (excluding dental fillings),
- history of migraines,
- psoriasis or eczema affecting the scalp,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS5x5 saline-soaked sponge electrodes will be used with the cathode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the anode will be placed on the right shoulder. The electrode placement will be the same across both conditions. | Device | Real tDCS |
| Placebosham tDCS to the right cerebellum | Other | Sham tDCS |
Primary outcome
Discourse: Picture Description
Time frame: Baseline 1: occurred at Visit 2 (after consent)
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Discourse Analysis: Picture Description
Time frame: Follow up 1: Visit 9. 2 weeks after Baseline 1
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Discourse: Picture Description
Time frame: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Picture Description
Time frame: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported for individual participants are raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Story Retell
Time frame: Baseline 1: occurred at Visit 2
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Discourse Analysis: Story Retell
Time frame: Follow up 1: Visit 9: 2 weeks after Baseline 1
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Discourse Analysis: Story Retell
Time frame: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Story Retell
Time frame: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1 points) or absent (0 points). The higher the score, the better the performance. Participant scores are reported as raw scores. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Procedural
Time frame: Baseline 1: Visit 2
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Discourse Analysis: Procedural
Time frame: Follow up 1: Visit 9: 2 weeks after Baseline 1
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Discourse Analysis: Procedural
Time frame: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Discourse Analysis: Procedural
Time frame: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0 points). Participant scores are reported as raw scores. There are no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Verbal Fluency: Semantic
Time frame: Baseline 1: Visit 2
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Verbal Fluency: Semantic
Time frame: Follow up 1: Visit 9: 2 weeks after Baseline 1
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Verbal Fluency: Semantic
Time frame: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Verbal Fluency: Semantic
Time frame: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many animals as they can in one minute. Norms for healthy adults is between 18-20 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17 items.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Verbal Fluency: Phonemic
Time frame: Baseline 1: Visit 2
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Verbal Fluency: Phonemic
Time frame: Follow up 1: Visit 9: 2 weeks after Baseline 1
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 1 and Follow up 1 refer to the first intervention condition in the cross over sequence.
Verbal Fluency: Phonemic
Time frame: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17.The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
Verbal Fluency: Phonemic
Time frame: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Verbal Fluency is a normed and standardized task of working memory and word recall. Participant will name as many words they can that start with either /f/ in one minute. Norms for healthy adults is between 25-35 items listed within the one minute timeframe. The number of items listed is the participants raw score. The higher the score, the better the performance. A score considered "no concerns" is >17. The minimum score is 0. There is no maximum score as this is a timed measure. There is no subscales for this measure. Baseline 2 and Follow up 2 reflect the second intervention in the cross over sequence.
8 secondary outcomes
Working Memory
Time frame: Baseline 1: Visit 2
Working Memory
Time frame: Follow up 1: Visit 9: 2 weeks after Baseline 1
Working Memory
Time frame: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Working Memory
Time frame: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2
Stroke Aphasia Quality of Life (SA-QOL)
Time frame: Baseline 1: Visit 2
Stroke Aphasia Quality of Life (SA-QOL)
Time frame: Follow up 1: Visit 9: 2 weeks after Baseline 1
Stroke Aphasia Quality of Life (SA-QOL)
Time frame: Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1
Stroke Aphasia Quality of Life (SA-QOL)
Time frame: Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1, 2 weeks after Baseline 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharyl A Samargia-Grivette, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Aphasia and Non-fluent Aphasia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discourse: Picture Description (time frame: Baseline 1: occurred at Visit 2 (after consent)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.