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Paired nTVNS Stimulation for Weakness of the Upper Extremity

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

Awards & highlights

Study 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

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.Check my eligibility

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change

Secondary outcome measures

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 more

Trial 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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NeuraStasis, IncLead Sponsor

Kirt Gill, MDStudy DirectorNeuraStasis, Inc

Sean Savitz, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

5 Previous Clinical Trials

305 Total Patients Enrolled

Frequently Asked Questions

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

What are the eligibility criteria for individuals to participate in this clinical study?

"To qualify for this research study, individuals must exhibit upper limb weakness and fall within the age range of 40 to 80. The trial plans to enroll approximately 25 participants."

Answered by AI

Is the enrollment for this study currently open?

"The trial mentioned on clinicaltrials.gov, which was initially released on March 1st, 2024 and last updated on February 23rd, 2024, is no longer seeking participants. However, it's worth noting that currently there are a staggering number of 1194 ongoing trials actively enrolling patients."

Answered by AI

Does this clinical trial allow participation by individuals who are older than 85 years?

"Eligibility for this research demands that potential candidates fall between the ages of 40 and 80. Notably, there are a significant number of studies available for individuals under 18 years old (47) and those over 65 years old (1159)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits

2024. "Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06288217.

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