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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Recent studies showed that a non-invasive, low-intensity brain stimulation called transcranial direct current stimulation (tDCS) can effectively increase motor neuron excitability in the brain and therefore promotes functional recovery after stroke. Thus, the overall purpose of this research project is to examine the effect of brain stimulation on motor skill learning in 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 data supports the effectiveness of the treatment Anodal Transcranial Direct Current Stimulation (a-tDCS) for stroke recovery?

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 stroke recovery by enhancing motor performance. ^{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 anodal transcranial direct current stimulation (a-tDCS) differ from other stroke treatments?

Anodal transcranial direct current stimulation (a-tDCS) is unique because it is a non-invasive brain stimulation technique that can enhance motor recovery by modulating brain activity, unlike traditional physical therapies. It is applied through electrodes on the scalp, making it different from drug-based treatments or invasive procedures. ^{1 4 5 11 12}

Research Team

Shih-Chiao Tseng, PhD

Principal Investigator

University of Texas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

References

1. 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]

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

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. Netherlands pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

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