Chronic AphasiaPhase 1tDCS- AphasiaNCT01651884
Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation
A Phase 1 study testing HD-tDCS (Soterix) and Transcranial Direct Current Stimulation (Neuroconn) in people with Chronic Aphasia, run by Soterix Medical.
Trial summary
The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Chronic Aphasia
- What is being tested?
- HD-tDCS (Soterix) and Transcranial Direct Current Stimulation (Neuroconn)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jan 2013
- Phase
- Phase 1
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- one-time ischemic stroke in the left hemisphere
- greater than 6-months post-stroke onset
- between 25 and 80 years of age
- aphasia diagnosis (as determined by pre-treatment language-based testing)
- right-handed (before the stroke)
- native speaker of English
- ability to provide informed written or verbal consent
Who cannot join
- clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
- factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
- prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
About this study
Official title: High Definition-transcranial Direct Current Stimulation (HD-tDCS) for Stroke Rehabilitation
The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more improvement after treatment when that treatment is accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver current to more specific locations in the brain. This new delivery method is called high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse current delivery) or HD-tDCS (more focal current delivery) will be the better approach for enhancing treatment outcomes. To answer this question, computerized speech-language treatment will be administered during the application of the different forms of brain stimulation.
- Conditions
- Chronic Aphasia
- Being tested
- HD-tDCS (Soterix), Transcranial Direct Current Stimulation (Neuroconn)
- Keywords
- Stroke, Anomia
- Medical subject headings
- Stroke, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCS (Soterix)Device
Also called Soterix Medical High-Definition M x N stimulator, Soterix Medical HDTargets
Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets
Transcranial Direct Current Stimulation (Neuroconn)Device
Also called Neuroconn
| Study group | Role | What they receive |
|---|---|---|
| High-Definition tDCS | Experimental | Not described Receives: Device: HD-tDCS (Soterix) |
| Sponge tDCS | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation (Neuroconn) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic AphasiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julius Fridriksson, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651884
- Sponsor's protocol ID
- Pro00015784
- Other IDs
- 1R41NS076123-01
- Acronym
- tDCS- Aphasia
- Status last verified
- Aug 2015
- First submitted
- 19 Jul 2012
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition-transcranial Direct Current Stimulation (HD-tDCS) for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT01651884
- Acronym / sponsor ID
- tDCS- Aphasia / Pro00015784
- Conditions
- Chronic Aphasia
- Keywords
- Stroke, Anomia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Jul 2012 (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.
The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more improvement after treatment when that treatment is accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver current to more specific locations in the brain. This new delivery method is called high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse current delivery) or HD-tDCS (more focal current delivery) will be the better approach for enhancing treatment outcomes. To answer this question, computerized speech-language treatment will be administered during the application of the different forms of brain stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Definition tDCS | Experimental | Device: HD-tDCS (Soterix) |
| Sponge tDCS | Experimental | Device: Transcranial Direct Current Stimulation (Neuroconn) |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- one-time ischemic stroke in the left hemisphere
- greater than 6-months post-stroke onset
- between 25 and 80 years of age
- aphasia diagnosis (as determined by pre-treatment language-based testing)
- right-handed (before the stroke)
Key exclusion criteria (3 listed)
- clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
- factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
- prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
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 |
|---|---|---|
| HD-tDCS (Soterix)Also: Soterix Medical High-Definition M x N stimulator, Soterix Medical HDTargetsSubjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets | Device | High-Definition tDCS |
| Transcranial Direct Current Stimulation (Neuroconn)Also: Neuroconn | Device | Sponge tDCS |
Primary outcome
Not reported in the source record.
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 26 Aug 2015.
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Effects of Recursive Self-feedback on Speech Production in Aphasia
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Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity
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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.
Julius Fridriksson, PhD principal investigator
University of South Carolina
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HD-tDCS (Soterix) and Transcranial Direct Current Stimulation (Neuroconn) in people with Chronic Aphasia, run by Soterix Medical.
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 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: finished, as of the sponsor's last update on 26 Aug 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 26 Aug 2015.