Brain Stimulation for Stroke

Overseen By Jessica M Cassidy, DPT, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Seizure activity, Pregnancy, Cognitive deficits, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if non-invasive brain stimulation can enhance communication between the brain and muscles in stroke survivors. Participants will receive two types of stimulation: one targets the brain's movement control area (Motor Brain Stimulation), and the other targets the vision control area (Visual Brain Stimulation). The trial includes a simple hand-squeezing task to assess improvement. It suits individuals who had a stroke over six months ago and experience arm weakness. As an unphased trial, participants can contribute to groundbreaking research that may lead to new stroke recovery therapies.

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

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

What prior data suggests that this brain stimulation technique is safe for stroke patients?

Previous studies have shown that non-invasive brain stimulation is safe for people who have had a stroke. Research indicates that methods like transcranial direct current stimulation (tDCS) are safe for aiding movement. One study found that using tDCS at levels of 2 mA or 4 mA did not cause any serious side effects. Similarly, repetitive transcranial magnetic stimulation (rTMS), another method for stimulating the brain to aid movement, also appears safe without major concerns.

For visual brain stimulation, studies have shown it to be safe as well. For instance, research using virtual reality-based rehabilitation, which visually stimulates the brain, found it to be practical and safe, with no major problems reported.

Participants in these studies did not experience serious negative effects, suggesting that both movement and visual brain stimulation are well-tolerated. While this trial may use different methods, the overall safety of similar brain stimulation techniques provides a reassuring background for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the brain stimulation techniques being tested for stroke recovery because they offer a non-invasive way to potentially enhance brain function and aid rehabilitation. Unlike traditional therapies like physical or occupational therapy, these techniques directly stimulate specific brain regions—either the motor or visual parts—aiming to improve motor skills and visual processing. This targeted approach could lead to more efficient and effective recovery, providing new hope for stroke survivors seeking faster, more noticeable improvements in their daily lives.

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

Research has shown that non-invasive brain stimulation can aid in stroke recovery. In this trial, participants will receive either motor brain stimulation or visual brain stimulation in different sequences. Studies have found that motor brain stimulation can improve movement by helping the brain reorganize and form new connections, a process known as neuroplasticity. Although less researched, visual brain stimulation also holds promise and might enhance motor recovery when combined with other treatments. Both methods aim to improve hand function in stroke survivors. ^{4 6 7 8 9}

Who Is on the Research Team?

Jessica M Cassidy, DPT, PT, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are experiencing difficulties with hand movements. Participants will undergo non-invasive brain stimulation while performing hand squeezing tasks to see if it improves muscle control.

Inclusion Criteria

I have had exactly one stroke, confirmed by medical records.

I have weakness in the arm opposite to the side of my stroke.

Ipsilesional motor-evoked potential response

Exclusion Criteria

I am currently in physical or occupational therapy or another clinical trial.

Impaired vision despite use of aid (e.g. glasses, contacts, etc.)

I have had a stroke in the cerebellum.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Single Research Visit

Participants complete a single research visit involving EEG and EMG setup, followed by three blocks of hand squeezing trials with non-invasive brain stimulation.

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the research visit.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Motor Brain Stimulation
• Visual Brain Stimulation

Trial Overview The study tests whether stimulating the motor or visual parts of the brain can enhance communication between the brain and muscles in stroke patients, potentially improving their ability to perform a hand squeezing task.

How Is the Trial Designed?

Group I: Visual then Motor Brain Stimulation Experimental Treatment 2 Interventions

Following the first block of 20 grip/squeeze trials completed without brain stimulation, participants will complete a second and third set of blocks where non-invasive brain stimulation just before each grip trial will occur. Participants randomized to the "visual then motor brain stimulation" arm will receive stimulation to the visual part of their brain first followed by non-invasive brain stimulation to the motor part of the brain. A 10-15 min participant break will separate the delivery of visual and motor brain stimulation (i.e., second and third blocks).

Group II: Motor then Visual Brain Stimulation Experimental Treatment 2 Interventions

Following the first block of 20 grip/squeeze trials completed without brain stimulation, participants will complete a second and third set of blocks where non-invasive brain stimulation just before each grip trial will occur. Participants randomized to the "motor then visual brain stimulation" arm will receive stimulation to the motor part of their brain first followed by non-invasive brain stimulation to the visual (occipital) part of the brain. A 10-15 min participant break will separate the delivery of motor and visual brain stimulation (i.e., second and third blocks).

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12303356/

Enhancing functional motor outcomes in chronic stroke Non-invasive brain stimulation (NIBS) promotes functional recovery by enhancing neuroplasticity and reorganizing brain networks.

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043159

Evidence of rTMS for Motor or Cognitive Stroke Recovery Repetitive transcranial magnetic stimulation holds the potential to benefit a range of motor and cognitive outcomes after stroke.

3. medrxiv.org medrxiv.org/content/10.1101/2025.06.03.25328922v1

Deep brain stimulation for post-stroke pain, cognitive and ... The study demonstrated a high 1-year response rate of 82% and a long-term response rate of 71%, defined as at least a 30% improvement in ...

4. nature.com nature.com/articles/s41598-025-07840-7

Non-invasive brain stimulation contributing to postural ... M1 stimulation demonstrated superior outcomes in stroke patients (SMD = 1.21, I2 = 74%), highlighting its critical role in reestablishing ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165027025001116

Application of non-invasive brain stimulation combined ... The findings suggest that rTMS promotes motor recovery in post-stroke patients by modulating brain activity and connectivity within motor networks.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922947/

Efficacy and safety of brain–computer interface for stroke ... BCI has a significant improvement effect on the upper limb motor function and the ADL of stroke patients, and the statistical results are stable ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1474442225000444

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, but it was safe, ...

8. nature.com nature.com/articles/s41591-023-02507-0

Cerebellar deep brain stimulation for chronic post-stroke ... No serious perioperative or stimulation-related adverse events were encountered, with participants demonstrating a seven-point median ...

9. 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, ...