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

Trial Summary

What is the purpose of this trial?

The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity.

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 Transcranial Direct Current Stimulation for stroke?

Transcranial Direct Current Stimulation (tDCS) has shown potential in improving motor function in stroke patients, especially those with chronic or mild-to-moderate impairments. While immediate improvements were not statistically significant, some studies suggest short-term benefits when tDCS is applied selectively. ^{1 2 3 4 5}

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

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no reports of serious or lasting harm in over 33,200 sessions across various populations, including potentially vulnerable groups. Common side effects are mild and temporary, such as itching, tingling, and headaches. ^{6 7 8 9 10}

How does the treatment Transcranial Direct Current Stimulation differ from other treatments for stroke?

Transcranial Direct Current Stimulation (tDCS) is unique because it uses a low electrical current applied to the scalp to potentially enhance motor recovery in stroke patients, especially when combined with physical therapy. Unlike traditional drug treatments, tDCS is non-invasive and focuses on modulating brain activity to improve motor function. ^{1 4 11 12 13}

Research Team

Timea Hodics, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

Transcranial direct current stimulation (tDCS): does it have merit in stroke rehabilitation? A systematic review. [2022]

2. 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]

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

Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. [2022]

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

Modulation of motor performance and motor learning by transcranial direct current stimulation. [2022]

5. Sweden pubmed.ncbi.nlm.nih.gov

Explore combined use of transcranial direct current stimulation and cognitive training on executive function after stroke. [2022]

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

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

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

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

8. 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]

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

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

10. England pubmed.ncbi.nlm.nih.gov

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

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

Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. [2018]

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

Transcranial direct current stimulation induces polarity-specific changes of cortical blood perfusion in the rat. [2022]

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

Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. [2018]