Brain Stimulation for Stroke

Overseen By Shih-Chiao Tseng, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Pregnancy, Metal implants, Seizures, others

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

Compensation: Varies

Number of Visits: 6

Duration: 5 sessions

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how brain stimulation might improve leg movement skills in people who have had a stroke. The main treatment tested is anodal Transcranial Direct Current Stimulation (a-tDCS), a non-invasive technique using a mild electrical current to stimulate the brain. Researchers aim to determine if this stimulation can aid leg mobility and balance, particularly in those who have experienced a stroke. The study seeks participants who had a stroke at least six months ago, have difficulty with leg movement, and can walk short distances independently. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

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 anodal transcranial direct current stimulation (a-tDCS) is safe for stroke survivors?

Research has shown that anodal transcranial direct current stimulation (a-tDCS) is generally safe. In studies, only 11.62% of reports mentioned side effects in stroke patients, with itching being the most common, occurring in about 70% of those cases. Other possible side effects include a mild burning sensation.

Additionally, studies have found that even at higher doses, a-tDCS did not cause serious safety issues. Most patients tolerated it well. This treatment has been tested in various settings and is deemed safe for further research in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using anodal Transcranial Direct Current Stimulation (a-tDCS) for stroke recovery because it offers a unique approach to enhancing brain activity and aiding rehabilitation. Unlike conventional treatments like physical therapy and medication, which focus on physical and chemical support, a-tDCS directly stimulates the brain with a mild electric current, potentially accelerating the brain's natural healing and learning processes. This method could lead to faster improvements in motor skills, balance, and cognitive functions, making it a promising addition to existing stroke recovery strategies.

What evidence suggests that anodal tDCS might be an effective treatment for stroke?

This trial will explore the effects of anodal transcranial direct current stimulation (a-tDCS) on stroke survivors. Studies have shown that a-tDCS can improve movement in individuals who have experienced a stroke. When applied to the brain's movement control area, a-tDCS can enhance brain function and aid recovery. It has proven especially effective in improving arm and hand movement. A recent review of several studies found that stroke patients receiving a-tDCS showed better movement recovery than those who did not. Overall, a-tDCS is considered safe and may enhance motor skills during stroke recovery. Participants in this trial will be divided into groups receiving real a-tDCS, sham tDCS, or no brain stimulation to assess its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Shih-Chiao Tseng, PT, PhD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for adults aged 21-90 who have had a stroke at least 6 months ago, affecting their leg movement but still able to walk and stand with or without help. They must have no severe joint stiffness, decent vision (with correction), and good enough mental function as shown by specific tests.

Inclusion Criteria

My MRI or CT scan shows that my stroke affected the corticospinal tract.

I can walk on my own for 10 meters, with or without help like a cane.

I can stand on my own for more than 30 seconds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo five sessions of brain stimulation combined with visuomotor stepping learning

5 sessions

5 visits (in-person)

Follow-up

Participants are monitored for changes in brain neuronal activations and stepping motor control

60 days

Multiple visits (in-person) on Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Anodal Transcranial Direct Current Stimulation (a-tDCS)

Trial Overview

The study is testing how brain stimulation using anodal transcranial direct current stimulation (a-tDCS) affects the ability to learn new leg movements in people who've had a stroke compared to those without strokes.

How Is the Trial Designed?

Group I: determine the effects of a-tDCS on the cortical excitation before and after locomotor learning Experimental Treatment 1 Intervention

measure changes in cortical neuronal activation before and after five sessions of locomotor skill training in healthy adults and stroke participants.

Group II: To explore the trends of functional improvements after five tDCS session in stroke survivors Experimental Treatment 1 Intervention

Compare functional improvements (gait performance, balance, motor and cognitive function) between healthy adults and stroke participants after five sessions of brain stimulation.

Group III: To explore improvements in learning capacity between healthy adults and stroke participants. Experimental Treatment 1 Intervention

Compare stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group.

Group IV: Explore the effects of brain stimulation on locomotor skill learning in stroke survivors Experimental Treatment 1 Intervention

To explore the trends of locomotor skill learning in three groups: stroke survivors after five sessions of anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after five sessions of sham tDCS (s-tDCS), and stroke survivors with no brain stimulation (control; CON).

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

In a study involving 10 chronic stroke patients, bihemispheric transcranial direct current stimulation (tDCS) combined with therapy led to significant improvements in motor function, with an average increase of 8.2 points on the Upper-Extremity Fugl-Meyer scale after two 5-day treatment periods.

The first treatment period showed a larger improvement (5.9 points) compared to the second period (2.3 points), indicating that while tDCS is effective, the benefits from multiple sessions may not increase linearly, which is important for future rehabilitation studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome. Lindenberg, R., Zhu, LL., Schlaug, G.[2021]

The study involving 26 healthy subjects found that five sessions of anodal transcranial direct current stimulation (tDCS) delivered over 24 hours were safe, with no serious adverse events reported, although mild side effects occurred in 27% of participants.

While 50% of subjects showed a significant increase in motor cortex excitability (as measured by motor evoked potential amplitudes), the response varied among individuals, indicating that not everyone benefits equally from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effects on motor cortex excitability of five anodal transcranial direct current stimulation sessions in 24hours. Zappasodi, F., Musumeci, G., Navarra, R., et al.[2019]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

The study involved 49 subacute stroke patients who participated in a 4-week robotic gait training program combined with transcranial direct current stimulation (tDCS), demonstrating that this combined approach is safe and feasible, with only one patient experiencing a minor side effect.

Despite improvements in gait speed and quality across all groups, the addition of tDCS targeting the leg motor cortex did not provide any additional benefits compared to robotic gait training alone or tDCS targeting the hand motor cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS does not enhance the effects of robot-assisted gait training in patients with subacute stroke. Leon, D., Cortes, M., Elder, J., et al.[2018]

Transcranial direct current stimulation (tDCS) significantly improves motor recovery in stroke patients, with effect sizes of 0.26 for upper limb and 0.47 for lower limb functions based on a meta-analysis of 29 studies involving 664 subjects.

Chronic stroke patients showed notable improvements in upper limb function after tDCS, while subacute stroke patients experienced more significant benefits for lower limb function, indicating that the timing and parameters of tDCS treatment are crucial for optimizing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. Bai, X., Guo, Z., He, L., et al.[2020]

In a clinical trial with 10 stroke patients, different tDCS electrode montages showed that bilateral and anodal stimulation of the affected primary motor cortex significantly improved upper limb function, as measured by the Jebsen-Taylor Test.

Sham stimulation and extra-cephalic tDCS did not produce significant effects, highlighting the importance of electrode placement in optimizing tDCS for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: electrode montage in stroke. Mahmoudi, H., Borhani Haghighi, A., Petramfar, P., et al.[2016]

A randomized, controlled trial with 26 patients showed that transcranial direct current stimulation (tDCS) applied to the left primary motor cortex, combined with intensive naming therapy, significantly improved naming abilities and functional communication in chronic aphasia, with effects maintained for up to 6 months.

The anodal-tDCS group demonstrated larger improvements in both trained and untrained naming tasks compared to the sham group, suggesting that this approach is a promising and clinically feasible method to enhance language recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the motor cortex enhances treatment outcome in post-stroke aphasia. Meinzer, M., Darkow, R., Lindenberg, R., et al.[2016]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S105230572400555X

Efficacy of anodal transcranial direct current stimulation for ...

Reported adverse reactions indicated that anodal transcranial direct current stimulation was relatively safe for stroke patients. Conclusions. Anodal ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8852708/

Effectiveness of transcranial direct current stimulation on hand ...

A meta-analysis of the efficacy of anodal transcranial direct current stimulation for upper limb motor recovery in stroke survivors. J Hand ...

3.

thelancet.com

thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00244-2/fulltext

Efficacy and safety of transcranial direct current stimulation ...

In patients with ischemic stroke, anodal tDCS applied to the motor cortex of the lesioned hemisphere over 10 days in the subacute phase was safe ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/strokeaha.113.001687

Safety and Efficacy of Transcranial Direct Current ...

Our data indicate that transcranial direct current stimulation exerts a measurable neuroprotective effect in the acute phase of stroke. However, ...

5.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.998953/full

Effectiveness of transcranial direct current stimulation over ...

Conclusions: Anodal-tDCS over the left DLPFC may be advantageous to the recovery of patients with MCS and clinically diagnosed with CVA or TBI.

6.

neurology.org

neurology.org/doi/10.1212/WNL.98.18_supplement.2892

Transcranial Direct Current Stimulation (tDCS) Enhanced ...

Study procedures were well tolerated, were feasible and safe. There was no significant difference in primary outcome measures between the tDCS ...

7.

thelancet.com

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

Safety and efficacy of transcranial direct current stimulation ...

We aimed to evaluate the safety and efficacy of three doses of tDCS in combination with modified constraint-induced movement therapy (mCIMT) in ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5389927/

Safety Review of transcranial Direct Current Stimulation in ...

Only 11.62% of published papers reported the occurrence of tDCS adverse effects in stroke patients. The most common was itching (70%), followed by burning ...

9.

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, ...

10.

nature.com

nature.com/articles/s41598-024-51839-5

Safety of ipsilesional anodal transcranial direct current ...

In this present study, we aimed to evaluate structural and behavioral safety of anodal tDCS applied in the acute phase of stroke.