Transcranial Direct Current Stimulation for Post-Stroke Motor Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation. Stimulating the brain can improve its function and help with recovery after a stroke. It has been a challenge to do this non-invasively. This is because the brain is reshaped after a stroke, and thus, it is difficult to find the right places to stimulate from the outside. In previous research, investigators found that optimal type and target of tDCS varied among subjects. The goal of this pilot trial is to test the feasibility of combining individually optimized, targeted high-definition tDCS (THD-tDCS) with rehabilitation therapy. Investigators will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from their previous research. The participants will be computer-randomized into two equal-sized groups to receive either optimal THD-tDCS or sham stimulation, together with rehabilitation therapy (modified constraint-induced movement therapy, mCIMT) for five sessions over two weeks. Outcome measures will be collected at the baseline and right after the final intervention session. The primary outcome measure will be the change in the FM-UE score from baseline to immediately post the final intervention to assess the immediate effect of the intervention on upper extremity motor impairment. The secondary outcome measure will be the Wolf Motor Function Test time score to evaluate the immediate effect on functional motor performance.
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either optimal THD-tDCS or sham stimulation with rehabilitation therapy for five sessions over two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Optimal targeted HD-tDCS (high-definition transcranial direct current stimulation) during Constraint Induced Movement Therapy (mCIMT)
Sham HD-tDCS (high-definition transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carle Foundation Hospital
Lead Sponsor
American Heart Association
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.