AphasiaNCT03773406
Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT)
A study testing Offline tDCS-before therapy, Offline tDCS-after therapy and Online tDCS in people with Aphasia, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Aphasia is an acquired (typically left-hemisphere) multi-modality disturbance of language that impacts around 2 million people in the USA. Aphasia impacts language production and comprehension as well as reading and writing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Offline tDCS-before therapy, Offline tDCS-after therapy and Online tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women with diagnosis of fluent or non-fluent aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by a MRI or CT scan
- Aphasia quotient on the WAB of 35-85
- At least 6 months post onset of aphasia (this is beyond the stage of spontaneous recovery)
- 18- 80 years of age
- Premorbidly fluent in English
- Premorbidly right-hand dominant per the Edinburg Handedness Inventory
Show all 9Show fewer
- Visual acuity of 20/40 corrected
- Auditory acuity no worse than 30 dB HL on pure tone testing, aided in the better ear.
- Education greater than 12th grade
Who cannot join
- Any other neurological condition (other than cerebral vascular disease) that could impact language and cognition such as Alzheimer's disease, Parkinson's disease, primary progressive aphasia, and traumatic brain injury
- Active substance use
- Individuals with epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Leora Cherney, PhD, 312-238-1117, lcherney@sralab.org
Sameer Ashaie, PhD, 312-238-6163, sameer.ashaie@northwestern.edu
About this study
Official title: Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT): An Intervention Development Study for Aphasia
Aphasia is an acquired (typically left-hemisphere) multi-modality disturbance of language that impacts around 2 million people in the USA. Aphasia impacts language production and comprehension as well as reading and writing. The ramifications of aphasia extend beyond language impairment to negatively impacting a person's social, vocational, and recreational activities. Currently, the most effective way to treat aphasia is with speech-language therapy (SLT). However, even if SLT is intensive, persons with aphasia are left with residual language delays. Recent research suggests that pairing SLT with transcranial direct current stimulation (tDCS) a non-invasive, safe, low-cost form of brain stimulation may aid language recovery in persons with aphasia. However, results from tDCS studies are inconclusive. The success of tDCS in combination with SLT could depend on the timing of tDCS since tDCS-induced effects depend on the neuronal state of the brain-networks at the time of the stimulation. In this study, the differential impact of tDCS before behavioral SLT (offline-before therapy), tDCS after SLT (offline-after therapy), and tDCS concurrently with SLT (online) on functional language recovery in persons with aphasia will be investigated. Sham tDCS (i.e., SLT alone) as a control group will also be included in the study. The investigators hypothesize that both offline and online tDCS will improve language functioning than sham tDCS.
Read the detailed description
tDCS Implementation:
2mA of direct current for 20 minutes will be delivered using a constant current stimulator via two electrodes in saline soaked sponges. To stimulate the left angular gyrus, a cathodal electrode inside a saline soaked sponge (5 x 3cm) will be placed over the CP5 according to the 10-20 international system for EEG electrode placement. The electrodes will be secured in position by a custom-built EEG cap that will be marked with the location for angular gyrus. The investigators will then confirm that the cathodal electrode is over the left angular through the use of neuronavigation. The "return" anode electrode will be placed in a saline soaked sponge (5 x 5cm) on the center of the supraorbital region.
At the beginning of the tDCS, current will slowly ram-up during the first few seconds until it reaches 2mA. The ramp-up process will acclimate the participants to tDCS-induced sensations (e.g., itching). At the end of the tDCS sessions, current will slowly ramp down in the last few seconds to 0mA. The total duration of the 2mA current will be maintained for 20 minutes. For sham stimulation, the investigators will place the electrodes in the same location as the real tDCS groups with stimulation ending after few seconds. The brief stimulation will produce tDCS-induced sensations so that participants will not be aware when the tDCS stopped delivering direct current
Speech-Language Treatment:
Standard-of-care treatment - script training will be used to provide SLT to our participants. The treatment will be delivered via a computer program, Aphasia Scripts ®, whereby a virtual therapist interactively guides the participants through treatment steps. Scripts will be five to ten sentences and developed from common templates about topics relevant to daily life (e.g., asking questions at the grocery store, ordering in a restaurant). The advantage of using a computer program instead of a human therapist is that it removes extraneous variables associated with human therapists (e.g., different levels of encouragement) and this, together with the use of script templates, ensures treatment fidelity across participants.
Duration of an individual subject's participation in the study:
Subjects will be requested to come for baseline sessions (3 to 4 hours) before the actual experiment. The baseline assessments may be done over two visits. In the baseline session the subjects' aphasia severity will be assessed. The participants will also perform baseline tasks of language and cognition in this session. Subjects will then participate in 3 weeks of tDCS and SLT (i.e., 15 sessions). The sessions will consist of 40 minutes of SLT and 20 minutes of tDCS. Subjects will be asked to return for an assessment immediately following the end of treatment and for follow-up testing after 4 and 8 weeks. Therefore, total number of visits will be 19-23 sessions (depending on how many visits are needed for the assessments) over a period of three months.
- Conditions
- Aphasia
- Being tested
- Offline tDCS-before therapy, Sham tDCS, Offline tDCS-after therapy, Online tDCS
- Keywords
- Aphasia, tDCS, Script training, Functional language, Naming
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offline tDCS-before therapyDevice
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Sham tDCSDevice
Stimulation will be given for a total 30 seconds (including ramp-up and ramp-down of current) and then the tDCS device will be turned off. The brief stimulation will produce tDCS-induced sensation so that participants will not be aware when the tDCS was turned off .We will use standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Offline tDCS-after therapyDevice
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Online tDCSDevice
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
| Study group | Role | What they receive |
|---|---|---|
| Offline tDCS-before therapy | Active comparator | Participants will receive 20 minutes of tDCS prior to the 40 minute speech-language therapy session. Receives: Device: Offline tDCS-before therapy |
| Offline tDCS-after therapy | Active comparator | Participants will receive 20 minutes of tDCS after the 40 minute speech-language therapy session. Receives: Device: Offline tDCS-after therapy |
| Online tDCS | Active comparator | tDCS will be applied at the beginning of the 40 minute speech-language therapy session and will last for 20 minutes. Receives: Device: Online tDCS |
| Sham tDCS | Sham comparator | Sham tDCS will be applied at the beginning of the 40 minute speech-language therapy session. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trained conversational script.
Changes in accuracy and rate of production on a trained conversational script from pre to post-treatment.
Measured: 3 weeks.
Secondary outcomes (4)
Change in untrained conversational script
Changes in accuracy and rate of production on an untrained conversational script from pre to post-treatment.
Measured: 3 weeks
Change in the Aphasia Quotient (AQ) of Western Aphasia Battery-Revised (WAB-R)
Changes in WAB-R AQ from pre and post treatment.
Measured: 3 weeks
Maintenance of trained conversational script
Accuracy and rate of production of trained conversational script at 4 weeks post-treatment
Measured: 7 weeks
Maintenance of trained conversational script
Accuracy and rate of production of trained conversational script at 8 weeks post-treatment
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start3 Apr 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
- Investigators
- Leora Cherney, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773406
- Sponsor's protocol ID
- 90IFRE0020
- Status last verified
- Jul 2022
- First submitted
- 10 Dec 2018
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ashaie SA, Engel S, Cherney LR. Timing of transcranial direct current stimulation (tDCS) combined with speech and language therapy (SLT) for aphasia: study protocol for a randomized controlled trial. Trials. 2022 Aug 17;23(1):668. doi: 10.1186/s13063-022-06627-9.
PubMed 35978374
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT): An Intervention Development Study for Aphasia
- ClinicalTrials.gov ID
- NCT03773406
- Acronym / sponsor ID
- 90IFRE0020
- Conditions
- Aphasia
- Keywords
- Aphasia, tDCS, Script training, Functional language, Naming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aphasia is an acquired (typically left-hemisphere) multi-modality disturbance of language that impacts around 2 million people in the USA. Aphasia impacts language production and comprehension as well as reading and writing. The ramifications of aphasia extend beyond language impairment to negatively impacting a person's social, vocational, and recreational activities. Currently, the most effective way to treat aphasia is with speech-language therapy (SLT). However, even if SLT is intensive, persons with aphasia are left with residual language delays. Recent research suggests that pairing SLT with transcranial direct current stimulation (tDCS) a non-invasive, safe, low-cost form of brain stimulation may aid language recovery in persons with aphasia. However, results from tDCS studies are inconclusive. The success of tDCS in combination with SLT could depend on the timing of tDCS since tDCS-induced effects depend on the neuronal state of the brain-networks at the time of the stimulation. In this study, the differential impact of tDCS before behavioral SLT (offline-before therapy), tDCS after SLT (offline-after therapy), and tDCS concurrently with SLT (online) on functional language recovery in persons with aphasia will be investigated. Sham tDCS (i.e., SLT alone) as a control group will also be included in the study. The investigators hypothesize that both offline and online tDCS will improve language functioning than sham tDCS.
Detailed description
tDCS Implementation:
2mA of direct current for 20 minutes will be delivered using a constant current stimulator via two electrodes in saline soaked sponges. To stimulate the left angular gyrus, a cathodal electrode inside a saline soaked sponge (5 x 3cm) will be placed over the CP5 according to the 10-20 international system for EEG electrode placement. The electrodes will be secured in position by a custom-built EEG cap that will be marked with the location for angular gyrus. The investigators will then confirm that the cathodal electrode is over the left angular through the use of neuronavigation. The "return" anode electrode will be placed in a saline soaked sponge (5 x 5cm) on the center of the supraorbital region.
At the beginning of the tDCS, current will slowly ram-up during the first few seconds until it reaches 2mA. The ramp-up process will acclimate the participants to tDCS-induced sensations (e.g., itching). At the end of the tDCS sessions, current will slowly ramp down in the last few seconds to 0mA. The total duration of the 2mA current will be maintained for 20 minutes. For sham stimulation, the investigators will place the electrodes in the same location as the real tDCS groups with stimulation ending after few seconds. The brief stimulation will produce tDCS-induced sensations so that participants will not be aware when the tDCS stopped delivering direct current
Speech-Language Treatment:
Standard-of-care treatment - script training will be used to provide SLT to our participants. The treatment will be delivered via a computer program, Aphasia Scripts ®, whereby a virtual therapist interactively guides the participants through treatment steps. Scripts will be five to ten sentences and developed from common templates about topics relevant to daily life (e.g., asking questions at the grocery store, ordering in a restaurant). The advantage of using a computer program instead of a human therapist is that it removes extraneous variables associated with human therapists (e.g., different levels of encouragement) and this, together with the use of script templates, ensures treatment fidelity across participants.
Duration of an individual subject's participation in the study:
Subjects will be requested to come for baseline sessions (3 to 4 hours) before the actual experiment. The baseline assessments may be done over two visits. In the baseline session the subjects' aphasia severity will be assessed. The participants will also perform baseline tasks of language and cognition in this session. Subjects will then participate in 3 weeks of tDCS and SLT (i.e., 15 sessions). The sessions will consist of 40 minutes of SLT and 20 minutes of tDCS. Subjects will be asked to return for an assessment immediately following the end of treatment and for follow-up testing after 4 and 8 weeks. Therefore, total number of visits will be 19-23 sessions (depending on how many visits are needed for the assessments) over a period of three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Offline tDCS-before therapy | Active comparator | Device: Offline tDCS-before therapyParticipants will receive 20 minutes of tDCS prior to the 40 minute speech-language therapy session. |
| Offline tDCS-after therapy | Active comparator | Device: Offline tDCS-after therapyParticipants will receive 20 minutes of tDCS after the 40 minute speech-language therapy session. |
| Online tDCS | Active comparator | Device: Online tDCStDCS will be applied at the beginning of the 40 minute speech-language therapy session and will last for 20 minutes. |
| Sham tDCS | Sham comparator | Device: Sham tDCSSham tDCS will be applied at the beginning of the 40 minute speech-language therapy session. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women with diagnosis of fluent or non-fluent aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by a MRI or CT scan
- Aphasia quotient on the WAB of 35-85
- At least 6 months post onset of aphasia (this is beyond the stage of spontaneous recovery)
- 18- 80 years of age
- Premorbidly fluent in English
Key exclusion criteria (3 listed)
- Any other neurological condition (other than cerebral vascular disease) that could impact language and cognition such as Alzheimer's disease, Parkinson's disease, primary progressive aphasia, and traumatic brain injury
- Active substance use
- Individuals with epilepsy
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 |
|---|---|---|
| Offline tDCS-before therapyDirect current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context. | Device | Offline tDCS-before therapy |
| Sham tDCSStimulation will be given for a total 30 seconds (including ramp-up and ramp-down of current) and then the tDCS device will be turned off. The brief stimulation will produce tDCS-induced sensation so that participants will not be aware when the tDCS was turned off .We will use standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context. | Device | Sham tDCS |
| Offline tDCS-after therapyDirect current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context. | Device | Offline tDCS-after therapy |
| Online tDCSDirect current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context. | Device | Online tDCS |
Primary outcome
Change in trained conversational script.
Time frame: 3 weeks.
Changes in accuracy and rate of production on a trained conversational script from pre to post-treatment.
4 secondary outcomes
Change in untrained conversational script
Time frame: 3 weeks
Change in the Aphasia Quotient (AQ) of Western Aphasia Battery-Revised (WAB-R)
Time frame: 3 weeks
Maintenance of trained conversational script
Time frame: 7 weeks
Maintenance of trained conversational script
Time frame: 11 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 35978374Ashaie SA, Engel S, Cherney LR. Timing of transcranial direct current stimulation (tDCS) combined with speech and language therapy (SLT) for aphasia: study protocol for a randomized controlled trial. Trials. 2022 Aug 17;23(1):668. doi: 10.1186/s13063-022-06627-9.
- Individual participant dataSharing planned: Undecided
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Leora Cherney, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offline tDCS-before therapy, Offline tDCS-after therapy and Online tDCS in people with Aphasia, run by Shirley Ryan AbilityLab 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leora Cherney, PhD (312-238-1117, lcherney@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trained conversational script. (time frame: 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773406, which also lists 1 linked publication.
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 26 Jul 2022.