tDCS for Post-Stroke Motor Impairment

Recruiting at 1 trial location

Overseen By Sanjiv Jain, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carle Foundation Hospital

Disqualifiers: Cognitive dysfunction, Pacemaker, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with major arm movement issues after a stroke. It uses transcranial direct current stimulation (tDCS), a gentle electrical stimulation to the brain, aimed at improving control in the affected limb. The trial includes different groups to test how tDCS affects specific brain areas, aiming to reduce muscle stiffness and enhance movement. It seeks participants with significant difficulty moving one arm due to a stroke. This unphased trial offers a unique opportunity to contribute to innovative research that could enhance recovery options 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. Please consult with the trial coordinators for more details.

What prior data suggests that this tDCS technique is safe for post-stroke motor impairment?

Studies have shown that transcranial direct current stimulation (tDCS) is generally safe for people who have had a stroke. This trial tests three main types of tDCS: bilateral, anodal, and cathodal.

Research suggests that bilateral tDCS is safe and well-tolerated. Many studies found that this brain stimulation can improve movement and reduce pain and muscle tightness in stroke patients without causing serious side effects.

For anodal tDCS, studies have confirmed its safety even with higher currents. Reviews of several trials show that this stimulation does not cause major side effects, making it a possible treatment for stroke recovery.

Cathodal tDCS also appears safe. In past studies, patients found it well-tolerated, especially when used soon after a stroke. No significant negative effects were noted, supporting its safety.

Overall, research indicates that these types of tDCS are safe for stroke patients. They are generally well-tolerated, with no major side effects reported in the studies reviewed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for post-stroke motor impairment because it offers a non-invasive and targeted approach to improving motor function. Unlike traditional rehabilitation therapies that often rely on physical exercises, tDCS uses electrical currents to stimulate specific areas of the brain, potentially enhancing neural connections and speeding up recovery. The bilateral stimulation approach targets both the lesioned and non-lesioned hemispheres, which might provide a more balanced and comprehensive treatment effect. Additionally, the option to use anodal or cathodal stimulation allows for tailored interventions based on individual patient needs. This versatility and precision could make tDCS a game-changer in stroke rehabilitation.

What evidence suggests that this trial's treatments could be effective for post-stroke motor impairment?

Research has shown that transcranial direct current stimulation (tDCS) can improve movement after a stroke. In this trial, participants will receive different types of tDCS. Bilateral tDCS, which targets both sides of the brain, reduces pain and muscle stiffness in the arms, common issues after a stroke. Anodal stimulation, which boosts brain activity in the affected area, enhances movement and daily activities. Cathodal stimulation, which calms overactivity on the unaffected side, also aids in better movement recovery. Overall, many studies support tDCS as effective for stroke rehabilitation, helping to improve movement and function in affected limbs. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for stroke survivors with significant motor impairments in one arm, who can consent to treatment. It's not suitable for those with abnormal muscle tone, severe limb wasting or sensory deficits, cognitive issues preventing understanding of the study, serious medical conditions, pacemaker users, metal implants in the head, known adverse reactions to TMS/tDCS or if pregnant.

Inclusion Criteria

I understand the details of the clinical trial and can consent to participate.

I have significant weakness in one arm.

Exclusion Criteria

Pregnant

I have muscle and movement issues in my limb that was not paralyzed.

My affected arm is very weak or has severe muscle loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo four different stimulation visits: anodal, cathodal, bilateral, and sham, with a 2-week washout period between each visit.

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial direct current stimulation (high- definition)

Trial Overview The trial tests targeted high-definition transcranial direct current stimulation (THD-tDCS) on reducing upper limb flexion synergy after a stroke. It will inhibit and facilitate specific brain regions to see if this improves motor function by modulating nerve tract excitability.

How Is the Trial Designed?

Group I: Bilateral Stimulation Active Control 1 Intervention

Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere and cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere at the same time.

Group II: Anodal stimulation Active Control 1 Intervention

Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere.

Group III: Cathodal stimulation Active Control 1 Intervention

Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.

Group IV: Sham stimulation Placebo Group 1 Intervention

Sham stimulation to both hemisphere of the brain

Transcranial direct current stimulation (high- definition) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as tDCS for:

• Stroke rehabilitation
• Motor disorders
• Neurological rehabilitation

Approved in European Union as tDCS for:

• Stroke rehabilitation
• Motor disorders
• Neurological rehabilitation

Approved in Canada as tDCS for:

• Stroke rehabilitation
• Motor disorders
• Neurological rehabilitation

Who Is Running the Clinical Trial?

Carle Foundation Hospital

Lead Sponsor

Trials

7

Recruited

720+

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Transcranial direct current stimulation (TDCS) applied to the affected hemisphere in 50 acute stroke patients was found to be safe, with no side effects reported during the treatment.

Despite being safe, the five daily sessions of anodal TDCS did not lead to significant improvements in motor deficits compared to sham treatment, indicating that TDCS may not enhance clinical outcomes in acute stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the affected hemisphere does not accelerate recovery of acute stroke patients. Rossi, C., Sallustio, F., Di Legge, S., et al.[2015]

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]

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) 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]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.

The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

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]

High-definition transcranial direct current stimulation (HD-tDCS) is feasible and acceptable for patients with chronic post-stroke aphasia, showing that it can be implemented effectively in a clinical setting with similar protocols to conventional sponge-based tDCS.

Preliminary results indicate that HD-tDCS may improve naming accuracy and response time in patients, with some evidence suggesting it could be more effective than conventional tDCS, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. Richardson, J., Datta, A., Dmochowski, J., et al.[2023]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

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) using a new montage improved the detection of right-hand motor imagery in 4 out of 5 healthy volunteers when applied for 10 minutes at the highest current density over the right-hand motor area.

While changes in EEG band power were not directly linked to improved classification accuracy, the study suggests that tDCS can influence different motor areas, indicating potential for enhancing motor neurorehabilitation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tDCS stimulation of motor cortex and cerebellum on EEG classification of motor imagery and sensorimotor band power. Angulo-Sherman, IN., Rodríguez-Ugarte, M., Sciacca, N., et al.[2018]

In a study involving 19 acute stroke patients with severe motor impairment, bihemispheric transcranial direct current stimulation (tDCS) combined with peripheral nerve stimulation did not show significant clinical or neurophysiological improvements compared to sham stimulation over a 12-month follow-up period.

Both treatment groups exhibited time-related changes in motor and sensory assessments, but there were no significant differences between the real and sham tDCS groups, suggesting that the severity of motor impairment may affect the efficacy of tDCS interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bihemispheric Transcranial Direct Current Stimulation Combined With Repetitive Peripheral Nerve Stimulation in Acute Stroke Patients. Yagüe, S., Veciana, M., Martínez-Yélamos, A., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388245721006003

The effects of transcranial direct current stimulation on ... Our results demonstrate that tDCS improves upper limb function post-stroke. However, its effectiveness depends on numerous factors. Especially chronic stroke ...

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1586685/full

Comparison of the effects of transcranial direct current ... This study employs network meta-analysis to assess the efficacy of transcranial direct current stimulation (tDCS) combined with different rehabilitation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11899689/

Effects of transcranial direct current stimulation (tDCS) on ... Studies have proven that stimulation can modulate cortical excitability, with anodal stimulation resulting in increased cortical excitability ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38585306/

A Randomized, Double-Blinded, Sham-Controlled Trial Conclusion: Both HD-tDCS and a-tDCS can improve upper limb motor function and daily activities of poststroke patients in the subacute stage.

5. research.aota.org research.aota.org/ajot/article/79/Supplement_2/7911500085p1/28115/Effects-of-Targeted-High-Definition-Transcranial

Effects of Targeted High-Definition Transcranial Direct Current ... PURPOSE: This study explores the use of high-definition transcranial direct current stimulation (HD-tDCS) to reduce motor deficits post-stroke.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X17306149

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. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-025-02795-2

Effects of transcranial direct current stimulation (tDCS) on ... This study systematically identified gaps and indicated that tDCS is a kind of potential and safe intervention.

9. nature.com nature.com/articles/s41598-025-04939-9

Effect of transcranial direct current stimulation on ... This study aims to investigate the effect of tDCS on dysphagia after hemispheric stroke and compare the effect of tDCS among three protocols.

10. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2019.00286/full

Single Sessions of High-Definition Transcranial Direct ... The purpose of this study was to determine the effects of a single session of anodal and cathodal HD-tDCS on gait kinematics and kinetics and ...