AphasiaNCT04041986
Transcranial Direct Current Stimulation Investigations of Language Processing in Aphasia
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Aphasia, run by University of Pennsylvania.
Trial summary
This study proposes to use transcranial direct current stimulation (tDCS) in patients with chronic strokes and aphasia in order to characterize and enhance the mechanisms of language recovery following injury. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jun 2015
- 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
- 1. Presence of aphasia attributable to one or more unilateral left hemispheric stroke(s)
- 2. The most recent stroke must have occurred 6 months prior to inclusion in the study
- 3. Must speak English as a native language
- 4. Must be able to understand the nature of the study, and give informed consent
Who cannot join
- 1. Subjects with bilateral strokes.
- 2. History of neurologic illness(es) other than stroke
- 3. Current unstable medical illness(es)
- 4. Epilepsy or Seizure(s) within the last six months
- 5. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
- 6. Subjects with Pacemakers or ICDs
Show all 9Show fewer
- 7. Diagnosed psychiatric disorders
- 8. Pregnancy
- 9. Current alcohol or drug abuse
About this study
This study proposes to use transcranial direct current stimulation (tDCS) in patients with chronic strokes and aphasia in order to characterize and enhance the mechanisms of language recovery following injury. Prior to enrollment subjects will undergo six "site-finding' sessions involving various placements of positively charged (anodal), negatively charged (cathodal), and sham stimulation over the damaged and intact hemispheres of the brain, along with standard tests of language. Subjects who are found to experience a transient improvement in language ability in this initial experiment will participate in an incomplete cross-over design study to determine if 10 sessions of tDCS stimulation lead to prolonged language benefit when delivered to the hemisphere and at the polarity shown previously to respond best to stimulation.
Read the detailed description
Transcranial Direct Current Stimulation (tDCS) uses a small (typically 1-2 mA) electrical current which is passed through the scalp and is delivered for up to 20 minutes. Due to the safety and tolerability of tDCS, as well as its demonstrated capacity to temporarily enhance cognitive, motor and affective functions of the brain, there has been an explosion of interest in the technique since the first reports in 2000. tDCS has been used safely in a wide variety of domains including studies of the visual system, working memory, verbal fluency and motor function. tDCS has also been used safely to enhance brain function in subjects with a variety of brain pathologies including stroke, depression and Alzheimers Disease. In this study, the investigators hope to address whether tDCS can be used to enhance language function in individuals with post-stroke aphasia.
This two part experiment will address 1) Can tDCS lead to transient improvement in language ability in individuals with stroke and chronic aphasia? and 2) Does repeated tDCS lead to prolonged improved language ability in individuals with stroke and chronic aphasia?
In Experiment 1, which will be referred to as the 'site-finding' portion of this protocol, participants will undergo anodal, cathodal, and sham stimulation of the intact or injured hemisphere to determine what area of the brain responds best to tDCS. There will be six separate sessions which are spaced apart by at least 2 days. Tests of language will be used to characterize changes in performance that are induced in each condition.
In Experiment 2, subjects who had participated in Experiment 1 and were found to experience a transient improvement in language ability after receiving tDCS will participate. Subjects will be stimulated using the best montage from Experiment 1. This is an incomplete cross-over design study to determine if 10 sessions of tDCS stimulation delivered to the brain will lead to improvement in language. Improvement will be operationally defined as performance on one or more language measures that is significantly better than baseline and sham performance (i.e. non-stimulation conditions). Half of our subjects will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of real tDCS. The other half of our subjects will be randomized to undergo sham stimulation before undergoing optional real tDCS stimulation. All subjects will engage in language rehearsal during stimulation. Tests of language will be used to characterize changes in performance that are induced by real and sham stimulation. Follow-up language testing will be performed at 2 weeks and 2 months after stimulation to determine whether tDCS can have prolonged effects on language.
- Conditions
- Aphasia
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- stroke, non-invasive brain stimulation, transcranial direct current stimulation (tDCS)
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that uses constant, low (1-2mA), direct current delivered via electrodes on the head.
| Study group | Role | What they receive |
|---|---|---|
| Site-Finding | Experimental | Each subject will receive anodal, cathodal, and sham stimulation to both the ipsilesional and contralesional hemispheres in a series of six sessions (one condition per session), each separated by at least two days. During anodal and cathodal tDCS sessions, subjects will receive stimulation for 20 minutes with a current of 2.0 mA using a 5x5 cm electrode. During sham tDCS, a 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The participant will complete pre/post language testing at each session in order to determine if the subject is a tDCS responder and if so, which site produces the best transient language improvement in that individual. Subjects who do not respond to tDCS will not be invited to move forward to the treatment phase. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Real tDCS | Active comparator | Half of our tDCS responders will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of real tDCS. During real tDCS sessions, subjects will receive stimulation for 20 minutes at a current of 2.0 mA with a 5x5 cm electrode at their optimal responder site previously determined. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS | Sham comparator | Half of our tDCS responders will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of sham tDCS. During sham tDCS, a 2.0 mA current will be delivered for approximately 30 seconds at the beginning of the sham condition before being extinguished over the course of seconds. Individuals randomized into the sham arm will be offered the option to crossover to real tDCS after their participation is complete. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in naming ability after tDCS at different brain areas
We will contrast naming ability before and after daily tDCS at 5 different brain regions. A change in naming ability as a function of tDCS to a specific brain region will be taken as evidence that stimulation of that brain region is relevant to the performance of the behavioral task in question.
Measured: 2 weeks
Change in overall aphasia severity after tDCS treatment
We will contrast overall aphasia severity before and after tDCS comparing real vs. sham stimulation. A decrease in aphasia severity which is greater at real stimulation vs. sham stimulation suggests that tDCS may be a viable tool to improving language in post-stroke aphasia.
Measured: Through study completion, about 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startJul 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- This is an incomplete crossover design where subjects randomized to the real tDCS group will end their participation but subjects randomized to the sham tDCS group will crossover into the real tDCS group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041986
- Sponsor's protocol ID
- 811842
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Investigations of Language Processing in Aphasia
- ClinicalTrials.gov ID
- NCT04041986
- Acronym / sponsor ID
- 811842
- Conditions
- Aphasia
- Keywords
- stroke, non-invasive brain stimulation, transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Aug 2019 (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.
This study proposes to use transcranial direct current stimulation (tDCS) in patients with chronic strokes and aphasia in order to characterize and enhance the mechanisms of language recovery following injury. Prior to enrollment subjects will undergo six "site-finding' sessions involving various placements of positively charged (anodal), negatively charged (cathodal), and sham stimulation over the damaged and intact hemispheres of the brain, along with standard tests of language. Subjects who are found to experience a transient improvement in language ability in this initial experiment will participate in an incomplete cross-over design study to determine if 10 sessions of tDCS stimulation lead to prolonged language benefit when delivered to the hemisphere and at the polarity shown previously to respond best to stimulation.
Detailed description
Transcranial Direct Current Stimulation (tDCS) uses a small (typically 1-2 mA) electrical current which is passed through the scalp and is delivered for up to 20 minutes. Due to the safety and tolerability of tDCS, as well as its demonstrated capacity to temporarily enhance cognitive, motor and affective functions of the brain, there has been an explosion of interest in the technique since the first reports in 2000. tDCS has been used safely in a wide variety of domains including studies of the visual system, working memory, verbal fluency and motor function. tDCS has also been used safely to enhance brain function in subjects with a variety of brain pathologies including stroke, depression and Alzheimers Disease. In this study, the investigators hope to address whether tDCS can be used to enhance language function in individuals with post-stroke aphasia.
This two part experiment will address 1) Can tDCS lead to transient improvement in language ability in individuals with stroke and chronic aphasia? and 2) Does repeated tDCS lead to prolonged improved language ability in individuals with stroke and chronic aphasia?
In Experiment 1, which will be referred to as the 'site-finding' portion of this protocol, participants will undergo anodal, cathodal, and sham stimulation of the intact or injured hemisphere to determine what area of the brain responds best to tDCS. There will be six separate sessions which are spaced apart by at least 2 days. Tests of language will be used to characterize changes in performance that are induced in each condition.
In Experiment 2, subjects who had participated in Experiment 1 and were found to experience a transient improvement in language ability after receiving tDCS will participate. Subjects will be stimulated using the best montage from Experiment 1. This is an incomplete cross-over design study to determine if 10 sessions of tDCS stimulation delivered to the brain will lead to improvement in language. Improvement will be operationally defined as performance on one or more language measures that is significantly better than baseline and sham performance (i.e. non-stimulation conditions). Half of our subjects will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of real tDCS. The other half of our subjects will be randomized to undergo sham stimulation before undergoing optional real tDCS stimulation. All subjects will engage in language rehearsal during stimulation. Tests of language will be used to characterize changes in performance that are induced by real and sham stimulation. Follow-up language testing will be performed at 2 weeks and 2 months after stimulation to determine whether tDCS can have prolonged effects on language.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is an incomplete crossover design where subjects randomized to the real tDCS group will end their participation but subjects randomized to the sham tDCS group will crossover into the real tDCS group.
| Arm | Type | Receives |
|---|---|---|
| Site-Finding | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)Each subject will receive anodal, cathodal, and sham stimulation to both the ipsilesional and contralesional hemispheres in a series of six sessions (one condition per session), each separated by at least two days. During anodal and cathodal tDCS sessions, subjects will receive stimulation for 20 minutes with a current of 2.0 mA using a 5x5 cm electrode. During sham tDCS, a 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The participant will complete pre/post language testing at each session in order to determine if the subject is a tDCS responder and if so, which site produces the best transient language improvement in that individual. Subjects who do not respond to tDCS will not be invited to move forward to the treatment phase. |
| Real tDCS | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)Half of our tDCS responders will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of real tDCS. During real tDCS sessions, subjects will receive stimulation for 20 minutes at a current of 2.0 mA with a 5x5 cm electrode at their optimal responder site previously determined. |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)Half of our tDCS responders will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of sham tDCS. During sham tDCS, a 2.0 mA current will be delivered for approximately 30 seconds at the beginning of the sham condition before being extinguished over the course of seconds. Individuals randomized into the sham arm will be offered the option to crossover to real tDCS after their participation is complete. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Presence of aphasia attributable to one or more unilateral left hemispheric stroke(s)
- 2. The most recent stroke must have occurred 6 months prior to inclusion in the study
- 3. Must speak English as a native language
- 4. Must be able to understand the nature of the study, and give informed consent
Key exclusion criteria (9 listed)
- 1. Subjects with bilateral strokes.
- 2. History of neurologic illness(es) other than stroke
- 3. Current unstable medical illness(es)
- 4. Epilepsy or Seizure(s) within the last six months
- 5. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that uses constant, low (1-2mA), direct current delivered via electrodes on the head. | Device | Real tDCS, Sham tDCS, Site-Finding |
Primary outcome
Change in naming ability after tDCS at different brain areas
Time frame: 2 weeks
We will contrast naming ability before and after daily tDCS at 5 different brain regions. A change in naming ability as a function of tDCS to a specific brain region will be taken as evidence that stimulation of that brain region is relevant to the performance of the behavioral task in question.
Change in overall aphasia severity after tDCS treatment
Time frame: Through study completion, about 2 months
We will contrast overall aphasia severity before and after tDCS comparing real vs. sham stimulation. A decrease in aphasia severity which is greater at real stimulation vs. sham stimulation suggests that tDCS may be a viable tool to improving language in post-stroke aphasia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Aphasia, run by University of Pennsylvania.
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 4 inclusion and 9 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 naming ability after tDCS at different brain areas (time frame: 2 weeks). The study lists 2 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 1 Aug 2019.