Brain Stimulation for Stroke

Overseen By Shih-Chiao Tseng, 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: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of brain stimulation called transcranial direct current stimulation (tDCS) to determine if it can help stroke survivors improve motor skills and walking abilities. Researchers aim to compare the effects of this stimulation on learning and motor skills in stroke survivors versus healthy adults. The trial includes different groups to explore these effects over time and after single and repeated sessions. Individuals who had a stroke more than six months ago, can walk independently, and have specific leg movement limitations might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance rehabilitation techniques for stroke survivors.

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 this brain stimulation technique is safe for stroke survivors?

Research shows that anodal transcranial direct current stimulation (a-tDCS) is generally safe for stroke patients when applied properly. Studies have found that patients usually tolerate a-tDCS well, with few reports of side effects. For instance, one study found that a-tDCS did not worsen motor function in stroke patients and was considered safe. Another study highlighted that a-tDCS is both practical and safe, even for those with other health conditions. While all treatments carry some risks, current evidence suggests that a-tDCS is a safe option for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about anodal transcranial direct current stimulation (a-tDCS) for stroke rehabilitation because it offers a unique approach to enhancing brain recovery. Unlike standard therapies that focus on physical exercises and medications, a-tDCS involves delivering a mild electrical current to the brain, which can boost neural activity and improve learning and motor skills. This non-invasive technique has the potential to accelerate recovery by directly stimulating brain regions responsible for movement and coordination. Additionally, it could offer a more accessible and cost-effective solution for stroke survivors seeking to regain their mobility and independence.

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

Research has shown that anodal transcranial direct current stimulation (a-tDCS) might help stroke survivors improve their movement abilities. In this trial, participants will be divided into different groups to explore various effects of a-tDCS. A review of eight studies found that a-tDCS can aid in the recovery of movement in the affected arm. Another study found it could also help with motor imagery, which involves mentally practicing movements, especially for those with severe movement issues. However, some research suggests that when combined with other therapies, a-tDCS doesn't always significantly improve movement problems. Overall, a-tDCS appears promising for helping stroke survivors regain motor skills. ^{3 6 7 8 9}

Who Is on the Research Team?

Shih-Chiao Tseng, PhD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 21-90 who can stand unassisted for at least 30 seconds, walk independently (with or without assistance), have a cognitive status score of ≥24 on the MMSE, no severe joint limitations, and corrected vision to 20/20. They must have had a unilateral stroke over 6 months ago with MRI or CT evidence affecting the corticospinal tract and some lower extremity weakness.

Inclusion Criteria

I can stand on my own for at least 30 seconds.

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

You need to have a good score on a test that measures memory and thinking skills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brain stimulation and locomotor skill training, including anodal tDCS and visuomotor stepping training

4 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of gait performance and neuronal activations

12 weeks

Assessments at Day 1, Day 7, Day 30, and Day 90

What Are the Treatments Tested in This Trial?

Interventions

• Anodal Transcranial Direct Current Stimulation (a-tDCS)

Trial Overview The study tests anodal transcranial direct current stimulation (a-tDCS) to see if it improves motor skill learning in post-stroke walking recovery. It's non-invasive brain stimulation that may increase motor neuron activity and aid functional recovery after a stroke.

How Is the Trial Designed?

Group I: To explore the trends of functional improvements after single a-tDCS session in stroke survivors. Experimental Treatment 1 Intervention

To explore functional improvements (gait performance, brain neural activation) between a-tDCS, s-tDCS, and control groups.

Group II: To explore the effect of brain stimulation on locomotor skill acquisition in stroke survivors Experimental Treatment 1 Intervention

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

Group III: To explore the accumulated effects of brain stimulation on gait improvements in stroke survivors Experimental Treatment 1 Intervention

To explore the accumulated, longitudinal trends of a four-week visuomotor stepping training in conjunction with brain stimulation on treadmill walking training and gait improvements for persons with chronic stroke.

Group IV: 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.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

The Claude D. Pepper Older Americans Independence Centers

Collaborator

Trials

11

Recruited

350+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39505058/

Efficacy of anodal transcranial direct current stimulation for ... The pooled results of these studies indicated that anodal transcranial direct current stimulation had a positive impact on the Fugl-Meyer Assessment Upper ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3600193/

Transcranial Direct Current Stimulation in Stroke Rehabilitation In spite of the limited sample size in this study, the result indicates that anodal tDCS is capable of improving motor imagery for severely incapacitated ...

3. 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, ...

4. jhandtherapy.org jhandtherapy.org/article/S0894-1130(12)00085-3/abstract

A meta-analysis of the efficacy of anodal transcranial direct ... This meta-analysis of eight randomized placebo-controlled trials provides further evidence that a-tDCS may benefit motor function of the paretic upper limb in ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-017-0301-7

Transcranial direct current stimulation (tDCS) for improving ... Comparing different forms of tDCS shows that cathodal tDCS is the most promising treatment option to improve ADL capacity in people with stroke.

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

Safety Review of transcranial Direct Current Stimulation in ... Current evidence shows that tDCS performed following the current safety guidelines [10] is well-tolerated by stroke patients; in few instances, adverse effects ...

7. 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.

8. 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, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7599981/

Feasibility and Safety of Transcranial Direct Current ... In this preliminary study, we found evidence that tDCS is feasible and safe for persons with stroke with other co-morbidities when applied in an ...