AphasiaNCT02622945
Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia
A study testing Active tDCS plus Speech-Language Therapy in people with Aphasia, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Active tDCS plus Speech-Language Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2020
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits
- Premorbid speakers of English
- Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment
- Stroke size: any l
- Location: Left hemisphere strokes only from any etiology.
- Time since stroke onset: 1 day to 20 years.
Who cannot join
- uncorrected visual or hearing impairment by self report
- other premorbid neurological disorder affecting the brain
- any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia
- premorbidly diagnosed with a developmental language disorder
- Pregnant women will also be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation in Acute and Chronic Post-stroke Aphasia
This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.
Read the detailed description
This study aims to determine whether behavioral word-retrieval therapy coupled with anodal tDCS will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition).
tDCS neuronal targets will be selected in this order:
- left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension),
- left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or
- right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted.
The same areas will be stimulated during the first tDCS and sham periods. If the participant returns for a second period of tDCS and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). For cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.
- Conditions
- Aphasia
- Being tested
- Active tDCS plus Speech-Language Therapy, Sham plus Speech-Language Therapy
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS plus Speech-Language TherapyDevice
Also called Active tDCS and speech-therapy
Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain not affected by the lesion(perilesional areas, right hemisphere or cerebellum). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
Sham plus Speech-Language TherapyDevice
Also called Sham tDCS plus speech-therapy
Speech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS plus Speech-Language Therapy | Experimental | Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized. Receives: Device: Active tDCS plus Speech-Language Therapy |
| Sham plus Speech-Language Therapy | Sham comparator | Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized. Receives: Device: Sham plus Speech-Language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in picture naming scores in trained and untrained items
Measured: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Secondary outcomes (4)
Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set
Measured: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Change in Written naming of objects and actions
The investigators will evaluate the absolute number as well as the percent change of the list of objects and actions assigned for intervention as trained and untrained items.
Measured: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Change in working memory (digit span)
Measured: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Change in verbal fluency
The investigators will use letter (F, A, S) and semantic fluency measures (animals, fruits and vegetables) and the investigators will measure how many were added or omitted at follow-up intervals.
Measured: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Study could not recruit any participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622945
- Sponsor's protocol ID
- NA00078932
- Status last verified
- Nov 2018
- First submitted
- 17 Nov 2015
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.
PubMed 21842404Dmochowski JP, Datta A, Huang Y, Richardson JD, Bikson M, Fridriksson J, Parra LC. Targeted transcranial direct current stimulation for rehabilitation after stroke. Neuroimage. 2013 Jul 15;75:12-19. doi: 10.1016/j.neuroimage.2013.02.049. Epub 2013 Mar 5.
PubMed 23473936
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in Acute and Chronic Post-stroke Aphasia
- ClinicalTrials.gov ID
- NCT02622945
- Acronym / sponsor ID
- NA00078932
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study could not recruit any participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- 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.
This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.
Detailed description
This study aims to determine whether behavioral word-retrieval therapy coupled with anodal tDCS will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition).
tDCS neuronal targets will be selected in this order:
- left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension),
- left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or
- right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted.
The same areas will be stimulated during the first tDCS and sham periods. If the participant returns for a second period of tDCS and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). For cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS plus Speech-Language Therapy | Experimental | Device: Active tDCS plus Speech-Language TherapyActive tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized. |
| Sham plus Speech-Language Therapy | Sham comparator | Device: Sham plus Speech-Language TherapySham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits
- Premorbid speakers of English
- Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment
- Stroke size: any l
- Location: Left hemisphere strokes only from any etiology.
Key exclusion criteria (5 listed)
- uncorrected visual or hearing impairment by self report
- other premorbid neurological disorder affecting the brain
- any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia
- premorbidly diagnosed with a developmental language disorder
- Pregnant women will also be excluded
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 |
|---|---|---|
| Active tDCS plus Speech-Language TherapyAlso: Active tDCS and speech-therapyStimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain not affected by the lesion(perilesional areas, right hemisphere or cerebellum). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming. | Device | Active tDCS plus Speech-Language Therapy |
| Sham plus Speech-Language TherapyAlso: Sham tDCS plus speech-therapySpeech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming. | Device | Sham plus Speech-Language Therapy |
Primary outcome
Change in picture naming scores in trained and untrained items
Time frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
4 secondary outcomes
Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set
Time frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Change in Written naming of objects and actions
Time frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Change in working memory (digit span)
Time frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Change in verbal fluency
Time frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Background: PubMed 21842404Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.
- Background: PubMed 23473936Dmochowski JP, Datta A, Huang Y, Richardson JD, Bikson M, Fridriksson J, Parra LC. Targeted transcranial direct current stimulation for rehabilitation after stroke. Neuroimage. 2013 Jul 15;75:12-19. doi: 10.1016/j.neuroimage.2013.02.049. Epub 2013 Mar 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS plus Speech-Language Therapy in people with Aphasia, run by Johns Hopkins University 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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Nov 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in picture naming scores in trained and untrained items (time frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups). 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 NCT02622945, which also lists 2 linked publications.
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 Nov 2018.