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Neuromodulation
Electrical Stimulation for Paresis
N/A
Recruiting
Led By Michael A. Urbin, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ALL PROSPECTIVE SUBJECTS: 18-75 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre, 1-week post, 1-month post
Awards & highlights
Summary
This trial aims to study how stimulating a nerve in the ear can affect the brain and potentially improve motor learning. The researchers believe that this stimulation can release certain chemicals in the brain that help with learning and
Who is the study for?
This trial is for individuals aged 18-75 who have had a stroke at least six months ago, resulting in hand impairment. It's not suitable for those with vestibular disorders, dizziness, ocular diseases affecting both eyes, seizures, epilepsy or incompatible implants. Pregnant women and people in other high-risk studies can't participate.
What is being tested?
The study tests whether electrical stimulation on the external ear (auricular stimulation) can help improve brain functions related to motor learning after a stroke. Participants will receive either real transcutaneous electrical stimulation or a sham (fake) treatment as part of the research.
What are the potential side effects?
While specific side effects are not detailed here, similar noninvasive neuromodulation treatments may cause mild discomfort at the site of stimulation, headache or skin irritation under electrode placement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre, 1-week post, 1-month post
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre, 1-week post, 1-month post
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Force Control Change
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Unpaired, Supra-Threshold StimExperimental Treatment1 Intervention
Supra-threshold stimulation after successful task repetition
Group II: Unpaired, Sub-Threshold StimExperimental Treatment1 Intervention
Sub-threshold stimulation after successful task repetition
Group III: Paired, Supra-Threshold StimExperimental Treatment1 Intervention
Supra-threshold stimulation paired with successful task repetition
Group IV: Paired, Sub-Threshold StimExperimental Treatment1 Intervention
Sub-threshold stimulation paired with successful task repetitions
Group V: ShamPlacebo Group1 Intervention
No stimulation
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,960 Total Patients Enrolled
7 Trials studying Paresis
198 Patients Enrolled for Paresis
Michael A. Urbin, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Paresis
66 Patients Enrolled for Paresis
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