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NCT06288217 · ClinicalTrials.gov registry record · NA
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits
A NA study of Stroke, Ischemic and Upper Extremity Paresis, sponsored by NeuraStasis.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06288217: Recruiting NA study of Stroke, Ischemic and Upper Extremity Paresis, sponsored by NeuraStasis.
NCT06288217 is a NA study of Stroke, Ischemic and Upper Extremity Paresis that is actively recruiting participants, run by NeuraStasis. The registered enrollment target is 25 participants, below the 289-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06288217, a NA study of Stroke, Ischemic and Upper Extremity Paresis, is actively recruiting participants, sponsored by NeuraStasis.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.
Primary Outcome
The Fugl-Meyer Assessment, Upper Limb (FMA-UE) will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Conditions Studied
Interventions
- DEVICE NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation)
- OTHER Upper Limb Rehabilitation
- OTHER Sham Stimulation
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2024-12 |
| Phase | NA |
What NCT06288217 shows while recruiting
NCT06288217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 289-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Stroke, Ischemic appearing as the primary indexed condition, and to 3 interventions - of which NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) is the first listed.
NCT06288217 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06288217 about?
NCT06288217 is a clinical study titled "Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits". This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the...
What is the current status of trial NCT06288217?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2024-03-05. Estimated completion is 2024-12.
What conditions does trial NCT06288217 study?
This clinical trial studies the following conditions: Stroke, Ischemic, Upper Extremity Paresis.
What interventions are being tested in trial NCT06288217?
The interventions under investigation include: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) (DEVICE), Upper Limb Rehabilitation (OTHER), Sham Stimulation (OTHER).
Who is sponsoring clinical trial NCT06288217?
This trial is sponsored by NeuraStasis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06288217 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06288217's enrollment target sits among peer trials
25 26th of 33 higher than 8 of 33 other Stroke, Ischemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke, Ischemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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