Transcranial Direct Current Stimulation for Stroke

Overseen By Amy Headlee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Epilepsy, Medical instability, others

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

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks for each treatment phase with a 4-8 week washout period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Soterix® tDCS (transcranial direct current stimulation) device, combined with home-based therapy, can improve language and thinking skills in individuals who have experienced a stroke, brain tumors, or certain brain conditions. It tests both home and lab settings, with participants receiving both real and placebo (inactive) treatments. Ideal participants are those who had a stroke or brain surgery at least three months ago and experience language or thinking problems that affect their daily lives. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery options for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that Transcranial Direct Current Stimulation (tDCS) is safe for treating cognitive-linguistic impairments?

Research has shown that transcranial direct current stimulation (tDCS) is safe for people. Studies have found that most individuals tolerate it well, experiencing only mild side effects like slight itching or tingling on the scalp.

The Soterix tDCS device used in this study has undergone testing in other trials. It delivers a low-level electrical current to the scalp, providing a gentle and well-tolerated method. This device is also user-friendly, even for beginners, which encourages consistent use at home.

Overall, evidence suggests that tDCS is safe for participants, with high levels of use and minimal discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for stroke rehabilitation because it offers a non-invasive way to enhance brain function. Unlike traditional methods like physical therapy or medication, tDCS uses a gentle electrical current to stimulate specific brain areas, potentially speeding up recovery. The study explores both home-based and lab-based treatments, giving patients flexibility in their recovery process. This innovative approach could provide a more accessible and efficient option for stroke survivors, making it a promising addition to existing care strategies.

What evidence suggests that this trial's treatments could be effective for stroke?

Research has shown that transcranial direct current stimulation (tDCS) can aid in recovering language skills after a stroke. Studies have found tDCS effective in enhancing language and cognitive abilities. The treatment applies a gentle electrical current to the scalp, promoting better cooperation among different brain areas. Early results also suggest improvements in movement, such as using arms and legs. In this trial, participants will receive either home-based or lab-based tDCS, with some starting with active stimulation and others with sham stimulation before crossing over. These positive effects make tDCS a promising option for those recovering from stroke-related challenges. ^{1 2 4 6 7}

Who Is on the Research Team?

Zafer Keser, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who are at least 3 months post-stroke or brain tumor treatment, and those with neurodegenerative conditions like Alzheimer's. They should have a life expectancy over 6 months and cognitive-linguistic impairments that affect their quality of life. Pregnant individuals, those with metal implants, medical instability, or epilepsy cannot participate.

Inclusion Criteria

Expected survival >6 months

Functional impairment in the domains of language and/or cognition affecting quality of life determined by PI

Have a legally authorized representative who is able to sign on their behalf in unable to consent for themselves (ex., individuals with aphasia)

Exclusion Criteria

Pregnancy

Contraindication to tDCS, including metallic implanted objects

Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sham tDCS followed by active tDCS, with home activity-based cognitive-linguistic therapy

4 weeks for each treatment phase with a 4-8 week washout period

12 sessions over 4 weeks for each treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Soterix® tDCS

Trial Overview The study tests if using Soterix® tDCS devices at home along with activity-based therapy can help improve cognitive-linguistic functions in patients recovering from strokes, brain tumors, or living with neurodegenerative diseases. It compares the effectiveness of home versus lab treatments.

How Is the Trial Designed?

Group I: Lab-Based Treatment: Sham Stimulation, Then Active Stimulation Experimental Treatment 1 Intervention

Subjects will be seen in person to first receive sham tDCS for 12 sessions over 4 weeks, and cross-over to the lab-based active treatment arm after an 8 week washout period.

Group II: Lab-Based Treatment: Active Stimulation, Then Sham Stimulation Experimental Treatment 1 Intervention

Subjects will be seen in person to first receive active tDCS for 12 sessions over 4 weeks, and cross-over to the lab-based sham treatment arm after an 8 week washout period.

Group III: Home-Based Treatment: Sham Stimulation, Then Active Stimulation Experimental Treatment 2 Interventions

Subjects will first receive sham tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based active treatment arm after a 4-8-week washout period.

Group IV: Home-Based Treatment: Active Stimulation, Then Sham Stimulation Experimental Treatment 2 Interventions

Subjects will first receive active tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based sham treatment arm after a 4-8-week washout period.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. soterixmedical.com soterixmedical.com/research/newsroom/clinicaltrials

Soterix Medical Clinical Trials A promising non-invasive treatment called transcranial direct current stimulation (tDCS) has shown potential benefits for patients with ALS. The study proposes ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07091396

Home Transcranial Direct Current Stimulation (tDCS) to ... The purpose of this study is to assess the feasibility of home-based Transcranial Direct Current Stimulation (tDCS) combined with a home activity based ...

3. soterixmedical.com soterixmedical.com/ct.php

Transcranial electrical stimulation for clincal trials The Soterix Medical 1x1-CT is the only tDCS stimulator allowing for both true double blind of experienced investigators and for simple operation by new users.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12029044/

Remotely Supervised Transcranial Direct Current ... Regarding efficacy, RS-tDCS preliminarily yielded improvements in upper- and lower-limb motor functions and increased language and cognitive ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1877065719300107

Transcranial direct current stimulation in post-stroke ... Several studies have shown the effectiveness of tDCS in improving language recovery in post-stroke aphasia.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01651884

Effects of tDCS Versus 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.

7. nature.com nature.com/articles/s41393-022-00768-z

Safety and efficacy of transcranial direct current stimulation ... The purpose of this clinical trial is to evaluate the safety, feasibility and efficacy of pairing noninvasive transcranial direct current stimulation (tDCS) ...