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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 below
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I understand the details of the clinical trial and can consent to participate.
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I have significant weakness in one arm.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention for reporting.

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: Cathodal stimulationActive Control1 Intervention
Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.
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: 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 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
320 Previous Clinical Trials
4,932,458 Total Patients Enrolled
38 Trials studying Stroke
3,924,043 Patients Enrolled for Stroke
University of OklahomaLead Sponsor
455 Previous Clinical Trials
98,091 Total Patients Enrolled
3 Trials studying Stroke
66 Patients Enrolled for Stroke

Media Library

Transcranial direct current stimulation (high- definition) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05479006 — N/A
Stroke Research Study Groups: Cathodal stimulation, Anodal stimulation, Bilateral Stimulation, Sham stimulation
Stroke Clinical Trial 2023: Transcranial direct current stimulation (high- definition) Highlights & Side Effects. Trial Name: NCT05479006 — N/A
Transcranial direct current stimulation (high- definition) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05479006 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially be included in this research endeavor?

"This clinical trial is recruiting 30 participants aged 18-90 who have experienced a stroke. To be eligible, they must demonstrate unilateral paresis with significant motor impairment of the affected upper limb and sign consent forms expressing their understanding of the study protocol."

Answered by AI

How many participants have been selected to participate in this trial?

"Yes, the online information from clinicaltrials.gov confirms that this experiment is still in search of participants. Initially posted on September 30th 2022 and edited most recently on October 11th 2022, it requires 30 enrollees at a single site."

Answered by AI

Is this study open to enrolment?

"According to clinicaltrials.gov, this research is actively enrolling participants; the trial was publicly published on September 30th 2022 and last modified eleven days later."

Answered by AI

Is this research study accommodating participants aged above 35?

"This medical trial stipulates that participants must be aged 18 or above, with the maximum age eligibility being 90 years of age."

Answered by AI
~14 spots leftby Jun 2025