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

Trial Summary

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 data supports the effectiveness of the treatment Anodal Transcranial Direct Current Stimulation (a-tDCS) for stroke?

Research shows that anodal transcranial direct current stimulation (a-tDCS) can improve motor function in stroke patients, with studies indicating significant improvements in upper limb function. This suggests that a-tDCS may help in the recovery of motor skills after a stroke. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans, with no serious or lasting side effects reported in over 33,200 sessions. Common mild effects include itching, tingling, and headaches, which are temporary and not significantly different from those experienced with a placebo. ^{6 7 8 9 10}

How does transcranial direct current stimulation (tDCS) differ from other stroke treatments?

Transcranial direct current stimulation (tDCS) is unique because it is a non-invasive brain stimulation technique that can enhance motor recovery after a stroke by modulating brain activity. Unlike traditional rehabilitation therapies, tDCS can be combined with these therapies to potentially improve outcomes, and it is applied using electrodes on the scalp, making it a relatively simple and accessible treatment option. ^{2 3 4 11 12}

What is the purpose of this trial?

This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.

Research Team

Shih-Chiao Tseng, PT, PhD

Principal Investigator

University of Texas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of anodal versus cathodal transcranial direct current stimulation on stroke rehabilitation: a pilot randomized controlled trial. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: electrode montage in stroke. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in stroke - Motor excitability and motor function. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

9. France pubmed.ncbi.nlm.nih.gov

Safety and effects on motor cortex excitability of five anodal transcranial direct current stimulation sessions in 24hours. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the motor cortex enhances treatment outcome in post-stroke aphasia. [2016]

12. Netherlands pubmed.ncbi.nlm.nih.gov

tDCS does not enhance the effects of robot-assisted gait training in patients with subacute stroke. [2018]