Your session is about to expire
← Back to Search
Device
tDCS for Post-Stroke Motor Impairment
N/A
Recruiting
Research Sponsored by Carle Foundation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capacity to provide informed consent
Paresis confined to one side, with substantial motor impairment of the paretic upper limb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Awards & highlights
Study Summary
This trial will test whether two different types of electrical brain stimulation can help people with motor impairments after a stroke.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of THD-tDCS may include discomfort at the electrode site on the scalp, itching or tingling during stimulation, fatigue post-treatment, headache or nausea. Serious side effects are rare but could involve seizures or skin burns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the details of the clinical trial and can consent to participate.
Select...
I have significant weakness in one arm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 1: Ispilesional stimulation in the brain and contralateral response in the muscle
Broca Aphasia
Secondary outcome measures
Change in Fugl-Meyer Upper Extremity assessment
Change in a subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergies
Other outcome measures
Modified Ashworth Scale
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Bilateral StimulationActive Control1 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 stimulationActive Control1 Intervention
Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere.
Group III: Cathodal stimulationActive Control1 Intervention
Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.
Group IV: Sham stimulationPlacebo Group1 Intervention
Sham stimulation to both hemisphere of the brain
Find a Location
Who is running the clinical trial?
Carle Foundation HospitalLead Sponsor
6 Previous Clinical Trials
691 Total Patients Enrolled
American Heart AssociationOTHER
333 Previous Clinical Trials
4,934,133 Total Patients Enrolled
39 Trials studying Stroke
3,924,856 Patients Enrolled for Stroke
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,626 Total Patients Enrolled
3 Trials studying Stroke
66 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have muscle and movement issues in my limb that was not paralyzed.My affected arm is very weak or has severe muscle loss.I do not have severe mental health issues that affect my understanding or communication.You have a pacemaker.I understand the details of the clinical trial and can consent to participate.I have significant weakness in one arm.I do not have severe health issues like heart or lung problems.I have metal implants in my head.You have had bad reactions to TMS and tDCS treatments in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Bilateral Stimulation
- Group 2: Anodal stimulation
- Group 3: Sham stimulation
- Group 4: Cathodal stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger