Chronic AphasiaPhase 2NCT02540109
Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study
A Phase 2 study testing HD-tDCS (Soterix Medical, Active) in people with Chronic Aphasia, run by Soterix Medical at 2 sites in United States.
Trial summary
This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Chronic Aphasia
- What is being tested?
- HD-tDCS (Soterix Medical, Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Sep 2019
- Phase
- Phase 2
- 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 75 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 75 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.
- Presence of Metal implants of claustrophobia (not able to undergo MRI)
- Pregnancy
- Presence of any other neurological disease than stroke
- Childhood history of speech, language, hearing, or intellectual impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina School of Medicine (Adam Jacks, Ph.D.)
Chapel Hill, North Carolina, 27514
Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)
Washington D.C., District of Columbia, 20057
About this study
Official title: Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia
This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.
- Conditions
- Chronic Aphasia
- Being tested
- HD-tDCS (Soterix Medical, Active), HD-tDCS (Soterix Medical, Sham)
- 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 Medical, Active)Device
Also called Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
HD-tDCS (Soterix Medical, Sham)Device
Also called Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
| Study group | Role | What they receive |
|---|---|---|
| High-Definition tDCS (Active) | Experimental | Not described Receives: Device: HD-tDCS (Soterix Medical, Active) |
| High-Definition tDCS (Sham) | Experimental | Not described Receives: Device: HD-tDCS (Soterix Medical, Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke
The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting.
Measured: 3 weeks
Secondary outcomes (1)
Determine alternate outcome measures
Determine alternate outcome measures, such as naming performance at 4 weeks and 6 months after treatment and improvements in more general discourse performance. An additional secondary exploratory objective is to perform a screening comparison of HD-tDCS with historical data on conventional non-targeted tDCS using sponge electrodes.
Measured: 4 weeks and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2019
- Study completionSep 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Georgetown University, University of North Carolina, Chapel Hill, The City College of New York, Medstar Health Research Institute, University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Abhishek Datta, Ph.D, Study chair, Soterix Medical Inc.Lucas C Parra, Ph.D, Study chair, City University of New York - CCNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540109
- Sponsor's protocol ID
- SMI092144-P2
- Other IDs
- 1R44NS092144
- Status last verified
- Dec 2023
- First submitted
- 31 Aug 2015
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia
- ClinicalTrials.gov ID
- NCT02540109
- Acronym / sponsor ID
- SMI092144-P2
- Conditions
- Chronic Aphasia
- Keywords
- Stroke, Anomia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Georgetown University, University of North Carolina, Chapel Hill, The City College of New York, Medstar Health Research Institute, University of South Carolina
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 3 Sep 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 Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Definition tDCS (Active) | Experimental | Device: HD-tDCS (Soterix Medical, Active) |
| High-Definition tDCS (Sham) | Experimental | Device: HD-tDCS (Soterix Medical, Sham) |
Who may qualify
- Ages
- 25 to 75 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 75 years of age
- aphasia diagnosis (as determined by pre-treatment language-based testing)
- right-handed (before the stroke)
Key exclusion criteria (7 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.
- Presence of Metal implants of claustrophobia (not able to undergo MRI)
- Pregnancy
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 Medical, Active)Also: Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargetsSubject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets. | Device | High-Definition tDCS (Active) |
| HD-tDCS (Soterix Medical, Sham)Also: Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargetsSubject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets. | Device | High-Definition tDCS (Sham) |
Primary outcome
Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke
Time frame: 3 weeks
The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting.
1 secondary outcome
Determine alternate outcome measures
Time frame: 4 weeks and 6 months follow up
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 5 Dec 2023.
- Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia.Link provided by the sponsor.
Related trials for Chronic Aphasia
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Recruiting
Effects of Recursive Self-feedback on Speech Production in Aphasia
Aphasia, Stroke
Not yet recruiting
Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity
Non-fluent Aphasia
Recruiting
Ecological Momentary Intervention for Post-Stroke Anomia
Post-Stroke Chronic Aphasia
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.
Abhishek Datta, Ph.D study chair
Soterix Medical Inc.
Lucas C Parra, Ph.D study chair
City University of New York - CCNY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HD-tDCS (Soterix Medical, Active) in people with Chronic Aphasia, run by Soterix Medical at 2 sites 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke (time frame: 3 weeks). 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 5 Dec 2023.