Transcranial Direct Current Stimulation for Stroke

Overseen By Rachel Markley, MOH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Severe psychiatric illnesses, Bilateral paresis, Severe uncontrolled medical problems, others

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Transcranial Direct Current Stimulation (tDCS), which uses a mild electrical current to potentially aid brain recovery after a stroke. The goal is to determine if this personalized approach can improve arm movement by enhancing brain connections. Participants will receive either the actual tDCS treatment or a sham version to compare results. The trial seeks stroke survivors who have experienced symptoms like weakness on one side for more than three months and can follow simple instructions. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new stroke recovery treatments.

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 transcranial direct current stimulation is safe for stroke patients?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for stroke patients. Only about 11.62% of reports mention any side effects, with itching being the most common, occurring in 70% of those who experience side effects.

One study confirmed that a single session of tDCS with a current up to 4 mA is safe and manageable. Even when combined with other treatments, tDCS does not increase side effects.

Overall, stroke patients seem to tolerate tDCS well, with only mild side effects like itching reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard stroke rehabilitation techniques that often involve physical therapy and medications, transcranial direct current stimulation (tDCS) offers a unique approach by directly stimulating the brain with a weak electrical current. This noninvasive method specifically targets the affected areas of the brain to potentially enhance recovery of motor functions in stroke patients. Researchers are excited about tDCS because it promises a personalized treatment experience, where the stimulation is customized for each patient based on initial testing results. This tailored approach, combined with the ability to directly influence neural pathways, could lead to faster and more effective recovery compared to traditional therapies.

What evidence suggests that transcranial direct current stimulation is effective for stroke?

Research suggests that Transcranial Direct Current Stimulation (tDCS) might aid stroke recovery, but results have been mixed. Some studies have shown that tDCS can enhance movement skills post-stroke, while others have not found significant benefits. In this trial, participants will receive either personalized tDCS, which adjusts the treatment to each person's brain, or a sham tDCS as a placebo comparator. Although evidence indicates that tDCS is safe, researchers continue to study its effectiveness to clarify these mixed results. While promising, more research is needed to confirm its benefits for stroke recovery. ^{3 4 6 7 8}

Who Is on the Research Team?

Timea Hodics, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had a stroke at least 3 months ago, resulting in partial paralysis but can still move their shoulder, elbow, wrist, and hand somewhat. They must be able to understand two-step commands and have a stroke confirmed by imaging. It's open to all races and genders with mild to moderate muscle stiffness.

Inclusion Criteria

I am over 18 years old and open to all races and genders.

My arm stiffness is mild.

I had a stroke that caused weakness on one side of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized transcranial direct current stimulation (ptDCS) during occupational therapy targeting the weaker arm for 10 sessions

4 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including fMRI functional connectivity biomarker assessment

4 weeks

Crossover (optional)

Participants in the sham group have the option to cross over and receive real tDCS treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests personalized brain stimulation (ptDCS) combined with occupational therapy (OT) against a sham treatment plus OT. The goal is to see if ptDCS can predict long-term improvement in stroke recovery by enhancing brain connectivity.

How Is the Trial Designed?

Group I: Personalized Transcranial direct current stimulation (ptDCS) Experimental Treatment 1 Intervention

TDCS is a noninvasive form of cortical stimulation that uses a battery-powered device. \[67\] Weak current (0.5-2 mA) will be delivered for up to 20 minutes through surface electrodes which will be positioned using the montage identified as the best in the individual stroke patient during our initial testing session during OT targeting the affected arm.

Group II: Sham tDCS Placebo Group 1 Intervention

Same OT procedure and montage as with the active stimulation but the current will be increased then decreased ramp-like and switched off after 20 seconds instead of the 20 minutes to elicit the same cutaneous sensation as the other stimulation conditions.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

In a study involving eight rats, transcranial direct current stimulation (tDCS) was found to significantly increase cerebral blood flow (CBF) when using anodal stimulation at higher current intensities (50 and 100 μA), with increases of about 18% and 25% respectively lasting for at least 30 minutes.

Conversely, cathodal tDCS decreased CBF, particularly at 100 μA, suggesting that the effects of tDCS on blood flow are polarity-specific and may be linked to changes in cortical excitability, indicating potential therapeutic applications for acute stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation induces polarity-specific changes of cortical blood perfusion in the rat. Wachter, D., Wrede, A., Schulz-Schaeffer, W., et al.[2022]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial direct current stimulation (tDCS) did not show significant improvements in motor performance for all stroke patients immediately after treatment, but it did demonstrate effectiveness in enhancing motor function for patients with chronic stroke and mild-to-moderate impairments, based on a review of 15 studies with 315 subjects.

The results suggest that while tDCS has potential as a therapeutic tool in stroke recovery, its efficacy varies based on stroke characteristics, indicating that more research is needed to optimize its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS): does it have merit in stroke rehabilitation? A systematic review. Marquez, J., van Vliet, P., McElduff, P., et al.[2022]

Transcranial direct current stimulation (tDCS) has shown promising results in enhancing motor learning and improving motor function in both healthy individuals and stroke patients, particularly when combined with targeted training.

tDCS is well tolerated and easy to use, with evidence suggesting that specific timing and electrode configurations can optimize its effectiveness for rehabilitation, although more acute studies in brain injury patients are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of motor performance and motor learning by transcranial direct current stimulation. Reis, J., Fritsch, B.[2022]

A study involving 18 stroke patients found that a single session of transcranial direct current stimulation (tDCS) at currents up to 4 mA is safe and well-tolerated, with no major safety concerns reported.

While 50% of patients experienced mild, transient skin redness, there were no significant changes in skin temperature or body resistance, indicating that higher currents do not compromise skin integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Chhatbar, PY., Chen, R., Deardorff, R., et al.[2018]

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]

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) 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]

A systematic review of nine studies involving 371 stroke patients found that transcranial direct current stimulation (tDCS) combined with rehabilitation showed a small non-significant effect on upper extremity recovery, with effect sizes of +0.11 for impairments and +0.24 for activities.

The variability in tDCS methodologies and rehabilitation programs suggests that while there may be some benefit, the current evidence is not strong enough to confirm its efficacy, indicating a need for further research to identify which patients may benefit most from specific tDCS treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. Tedesco Triccas, L., Burridge, JH., Hughes, AM., et al.[2022]

Transcranial direct current stimulation (tDCS) combined with cognitive training significantly improved executive function and performance in daily activities among 50 stroke patients, as measured by various cognitive tests.

While most cognitive assessments showed significant improvements in the tDCS group compared to the sham group, some specific tasks related to daily living did not show notable differences, indicating that tDCS may be more effective for certain cognitive functions than others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explore combined use of transcranial direct current stimulation and cognitive training on executive function after stroke. Liu, YW., Chen, ZH., Luo, J., 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]

In a study involving 44 stroke patients, those who received anodal transcranial direct current stimulation alongside constraint-induced movement therapy showed greater improvements in upper limb function compared to those who received sham stimulation.

Both treatment groups improved on the Wolf Motor Function Test, but the anodal stimulation group had significantly better outcomes, indicating that this combination therapy may enhance rehabilitation effectiveness for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Figlewski, K., Blicher, JU., Mortensen, J., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7153501/

Transcranial Direct Current Stimulation for Post-Stroke ... However, data on tDCS efficacy in stroke motor recovery have been mixed and inconsistent, leaving several issues to be resolved before tDCS is ready for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36552133/

MRI-Based Personalized Transcranial Direct Current ... This study aims to determine the effectiveness of personalized tDCS using brain MRI-based electrical field simulation and optimization, to ...

3. 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, ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000204444

Efficacy of Transcranial Direct Current Stimulation on ... This study actively aims to thoroughly evaluate the effectiveness of tDCS in alleviating post-stroke fatigue and strives to make significant contributions to ...

5. 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, ...

6. 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28279641/

Safety and Tolerability of Transcranial Direct Current ... Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients.

8. 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.