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Nerve Stimulation for Stroke Recovery
Houston, TX
N/A
Recruiting
Led By Sean Savitz, MD
Research Sponsored by NeuraStasis, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation
Summary
This trial aims to study the effects of non-invasive electrical stimulation on the nerves in the arm of people who have had a stroke. The study will involve up to 25 participants with arm weakness after
See full description
Who is the study for?
This trial is for up to 25 people who have had an ischemic stroke at least six months ago and are still experiencing weakness in their arms. The study will test a new treatment alongside regular arm rehabilitation.
What is being tested?
The trial is testing the NeuraStasis Stimulator System, which gives non-invasive electrical stimulation to nerves in the face and neck, as an additional treatment during upper limb rehab for stroke recovery.See study design
What are the potential side effects?
Possible side effects may include discomfort or skin irritation where the device attaches, headache, fatigue, or other reactions related to nerve stimulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
Secondary study objectives
Action Research Arm Test (ARAT) Average Change
Analysis of the number of stimulations per therapy session
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response %
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Paired nTVNS StimulationExperimental Treatment2 Interventions
Non-invasive electrical stimulation of the trigeminal and vagus nerves will be delivered by the NeuraStasis Stimulator System. The non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear). The operator controls the stimulation delivery through the accompanying Controller.
Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A 15-minute priming stimulation is delivered next, followed by the standard of care rehabilitation over the remaining session. During this rehabilitation paired nTVNS is delivered with repetitive motions.
Group II: Sham StimulationPlacebo Group2 Interventions
For the active shame comparator group, the non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear) as in the experimental group. The operator controls the stimulation delivery through the accompanying Controller.
Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A sham stimulation dosage will follow for the remaining procedure, including the priming stimulation, period and the standard of care rehabilitation
Find a Location
Closest Location:The University of Texas Health Science Center at Houston· Houston, TX
Who is running the clinical trial?
NeuraStasis, IncLead Sponsor
Sean Savitz, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
5 Previous Clinical Trials
296 Total Patients Enrolled
2 Trials studying Ischemic Stroke
260 Patients Enrolled for Ischemic Stroke
Kirt Gill, MDStudy DirectorNeuraStasis, Inc