Transcranial Direct Current Stimulation for Post-Stroke Motor Impairment

YY
SJ
Overseen BySanjiv Jain, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), can improve recovery for stroke patients with arm movement problems. Participants will receive either real or sham (fake) brain stimulation, combined with modified constraint-induced movement therapy (mCIMT), which encourages use of the affected arm. This trial targets individuals who have experienced a stroke affecting one side of the body and still struggle significantly with arm movement. The goal is to assess whether this combined approach can enhance motor function and improve performance in everyday tasks. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could advance stroke recovery therapies.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently undergoing anti-malarial treatment, you must discontinue it before participating.

What prior data suggests that this transcranial direct current stimulation is safe for post-stroke motor impairment?

A previous study showed that high-definition transcranial direct current stimulation (HD-tDCS) was safe and well-tolerated in older adults, with no serious side effects. This non-invasive brain stimulation method uses mild electrical currents to improve brain function and has been used in stroke recovery without major issues. Some minor side effects, such as tingling or itching on the scalp, have been reported but are usually mild and temporary.

Modified constraint-induced movement therapy (mCIMT) is another part of the treatment and is also considered safe for stroke recovery. This therapy involves using the weaker arm more often, which can help improve its function over time. Studies have shown that mCIMT can be effective without causing harm.

Overall, research has found both treatments to be generally safe for people recovering from a stroke.12345

Why are researchers excited about this trial?

Researchers are excited about the use of transcranial direct current stimulation (tDCS) combined with modified constraint-induced movement therapy (mCIMT) for treating post-stroke motor impairment because it introduces a unique approach to rehabilitation. Unlike traditional therapies that primarily involve physical exercises and repetitive tasks, tDCS offers a non-invasive way to stimulate brain activity and enhance neural plasticity. This high-definition brain stimulation, especially when optimally targeted, might enhance recovery by promoting the brain's natural ability to rewire itself. The combination with mCIMT, which already encourages movement in the affected limbs by restricting the unaffected ones, could potentially lead to faster and more effective improvements in motor function.

What evidence suggests that high-definition transcranial direct current stimulation (THD-tDCS) is effective for post-stroke motor impairment?

This trial will compare the effects of optimal targeted high-definition transcranial direct current stimulation (HD-tDCS) combined with modified constraint-induced movement therapy (mCIMT) to a sham HD-tDCS combined with mCIMT. Studies have shown that HD-tDCS can improve movement after a stroke. In one study, six out of nine patients experienced better arm and hand movement following HD-tDCS treatment. Another study found that combining HD-tDCS with rehabilitation exercises further aids recovery. This non-invasive method helps the brain adapt and heal. While the results are promising, individual responses can vary, and more research is needed to confirm these findings.13567

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have had a stroke causing weakness on one side of the body, with moderate to severe arm or hand movement problems. Participants must be able to consent and participate in English, have recent brain imaging from Carle, and not have severe muscle wasting, contractures, major sensory loss, or serious medical issues.

Inclusion Criteria

* Must have had either MRI or CT of the brain performed at Carle as part of their stroke care. Imaging may have been performed either during the diagnostic work-up for stroke or as follow-up after diagnosis. The most recent images from either MRI or CT will be collected for this study.
My arm function score is between 8 and 50 on the Fugl-Meyer scale.
I have significant weakness in my affected arm.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either optimal THD-tDCS or sham stimulation with rehabilitation therapy for five sessions over two weeks

2 weeks
5 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High-definition transcranial direct current stimulation (THD-tDCS)
  • Modified constraint-induced movement therapy (mCIMT)

Trial Overview

The study compares two groups: one receives personalized high-definition transcranial direct current stimulation (HD-tDCS) plus specialized rehab therapy for arm/hand recovery after stroke; the other gets sham (inactive) stimulation with the same rehab. Both groups get five sessions over two weeks.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Optimal targeted HD-tDCS + mCIMTActive Control2 Interventions
Group II: Sham HD-tDCS + mCIMTPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carle Foundation Hospital

Lead Sponsor

Trials
7
Recruited
720+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Citations

Efficacy and safety of high-definition transcranial direct current ...

This study aims to confirm the efficacy and safety of HD-tDCS combined with digital upper limb rehabilitation in improving upper limb motor ...

High-definition transcranial direct current stimulation for ...

This proof-of-concept study aims to develop a non-invasive brain stimulation protocol that facilitates the lesioned CST and inhibits the contralesional CRST.

Simultaneous high-definition transcranial direct current ...

This study investigates whether simultaneous high-definition transcranial direct current stimulation (HD-tDCS) enhances the effects of robot-assisted gait ...

Effects of Targeted High-Definition Transcranial Direct Current ...

RESULTS: Six out of nine participants with initial FM-UE scores between 22-37 had increases in FM-UE scores after at least one active HD-tDCS ...

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, ...

Safety Review of transcranial Direct Current Stimulation ... - PMC

This review analyzes the reported adverse effects in stroke, looking for factors that may induce side-effects.

Safety and efficacy of transcranial direct current stimulation ...

Safety and efficacy of transcranial direct current stimulation in addition to constraint-induced movement therapy for post-stroke motor recovery (TRANSPORT2)