Brain Stimulation for Stroke and Aphasia

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Syracuse University

Disqualifiers: Neurological disorder, Seizures, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 2-3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a gentle electrical brain stimulation called transcranial direct current stimulation (tDCS) can improve fatigue and language issues in stroke survivors. Researchers aim to determine if active brain stimulation is more effective than a sham version in reducing these problems. Participants will join one of several groups, receiving different combinations of tDCS and language therapy. Individuals who had a stroke over six months ago, experience mild to moderate aphasia, and feel post-stroke fatigue might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance post-stroke recovery options.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are managing anxiety or depression with medication, you can still participate.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for stroke patients?

Research has shown that transcranial direct current stimulation (tDCS) is a safe and noninvasive technique. It applies a gentle electrical current to the brain to aid recovery after a stroke. Studies indicate that patients tolerate tDCS well and experience no pain. Specifically, one study found that a single session with a current up to 4 mA is safe for stroke patients. Moreover, these studies reported no significant negative effects. While still under investigation, tDCS appears to be a promising method for improving language and movement abilities after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial Direct Current Stimulation (tDCS) for stroke and aphasia because it offers a non-invasive way to potentially enhance brain recovery. Unlike traditional speech therapy alone, tDCS aims to boost brain function by applying a gentle electrical current to specific brain areas, which might enhance the effects of language treatments. This method is particularly promising because it could accelerate improvement in language skills when combined with targeted therapies, possibly leading to faster and more effective recovery for patients.

What evidence suggests that this trial's treatments could be effective for improving post-stroke fatigue and aphasia?

Research has shown that transcranial direct current stimulation (tDCS) can assist people with post-stroke aphasia, a language difficulty following a stroke. In this trial, participants will receive various treatment combinations. Some will undergo active tDCS with attention-focused language treatment, which enhances speech content and object-naming ability. Others will receive active tDCS with sentence picture matching treatment, which has improved naming accuracy and overall language skills. These findings suggest that tDCS can be a valuable tool for regaining language abilities after a stroke. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for stroke survivors experiencing fatigue and aphasia, which affects their language and communication. Participants should be able to undergo brain stimulation therapy and attend multiple sessions. Those with certain metal implants, skin conditions at the stimulation site, or severe cognitive impairments may not qualify.

Inclusion Criteria

Not pregnant

Does not currently have cardiac pacemaker

No metal implants in the scalp or bone in the pre-frontal area of the head

Exclusion Criteria

Currently has cardiac pacemaker

Unwilling to allow audio-recording of study sessions

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 sessions of transcranial direct current stimulation (tDCS) plus speech and language therapy

2-3 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person) within 1 week after treatment, 1 visit (in-person) at 3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests if transcranial direct current stimulation (tDCS) on the pre-frontal areas of the brain can reduce post-stroke fatigue and improve language skills when combined with speech therapy. It compares active tDCS against a sham (placebo-like) treatment over ten sessions.

How Is the Trial Designed?

Group I: active tDCS plus attention-focused language treatment Experimental Treatment 2 Interventions

active tDCS and attention focused language treatment will be administered

Group II: active tDCS plus sentence picture matching treatment Active Control 2 Interventions

active tDCS and sentence picture matching treatment will be administered

Group III: sham tDCS plus attention-focused language treatment Placebo Group 2 Interventions

sham tDCS and attention focused language treatment will be administered

Group IV: sham tDCS plus sentence picture matching treatment Placebo Group 2 Interventions

sham tDCS and sentence picture matching treatment will be administered

Who Is Running the Clinical Trial?

Syracuse University

Lead Sponsor

Trials

54

Recruited

118,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000885

Effect of transcranial direct current stimulation combined ... tDCS combined with SLT demonstrates potential enhancement in language recovery on post-ischemic stroke aphasia. The combination may augment speech content, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6528187/

Transcranial direct current stimulation (tDCS) for improving ... This technique manipulates brain functions and may be used to improve language difficulties. However, the effectiveness of this intervention for improving SLT ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.01089/full

Transcranial Direct Current Stimulation to Enhance ... In summary, preliminary data suggest that anodal-tDCS can benefit naming and communication ability in chronic post-stroke aphasia, with medium-to-large effect ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05386394

NCT05386394 | Transcranial Direct Current Stimulation in ... Each treatment period will last 3 weeks, with 5 language therapy sessions/week, for 15 sessions in total, and a 3-month (stimulation-free) wash-out time between ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02687038.2025.2550016?src=

Transcranial direct current stimulation (tDCS) for persons ... Only 4.4% had hands-on experience administering tDCS. Notably, 80% perceived tDCS as an augmentative method to traditional speech-language therapy, with many ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7346463/

Transcranial direct current stimulation (tDCS) for improving ... tDCS is an emerging approach for improving aphasia after stroke. However, it remains unclear what type of tDCS stimulation is most effective.

7. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.041557

Transcranial Direct-Current Stimulation in Subacute Aphasia tDCS is a safe, noninvasive, nonpainful electrical stimulation of the brain, which modulates cortical excitability by applying weak electrical ...

8. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(25)00044-4/abstract

Safety and efficacy of transcranial direct current stimulation ... tDCS at doses of 2 mA or 4 mA, in addition to mCIMT, did not lead to further reduction in motor impairment in patients 1–6 months after stroke, ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28279641/

Safety and tolerability of transcranial direct current stimulation ... Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients.