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Neuromodulation

Vagus Nerve Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Rita Hamilton, DO

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must demonstrate some residual upper limb and hand movement in either arm

Adult, aged 18-64

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 1 through study follow-up, approximately two years from the date of implant

Awards & highlights

Study Summary

This trial is testing whether or not a new device that delivers vagus nerve stimulation is safe and effective in reducing symptom severity in participants with spinal cord injuries.

Who is the study for?

Adults aged 18-64 with a spinal cord injury from trauma at least one year ago, who have some upper limb movement and are in good health. Candidates must be able to follow the study protocol and agree to VNS implantation surgery. Excluded are those with conditions affecting rehabilitation, cognitive deficits preventing informed consent, recent syncope or dysphagia, non-English speakers, pregnant or lactating individuals, substance abusers, participants in other trials, and those with significant medical issues.Check my eligibility

What is being tested?

The trial is testing vagus nerve stimulation (VNS) delivered by a new device during rehabilitation exercises for improving motor function in people with spinal cord injuries. It's a double-blind study where half of the participants will receive active VNS and the other half a placebo while undergoing training sessions.See study design

What are the potential side effects?

Potential side effects may include discomfort at the implant site, voice changes due to nerve stimulation, throat pain or tingling sensation during activation of the device. More serious risks could involve surgical complications or adverse reactions to electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my arms and hands a little.

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I am between 18 and 64 years old.

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I have a first-time cervical spinal cord injury with some motor function, graded B, C, or D.

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I have a first-time cervical spinal cord injury with some motor function, graded B, C, or D.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 1 through study follow-up, approximately two years from the date of implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 1 through study follow-up, approximately two years from the date of implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 through study follow-up, approximately two years from the date of implant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Adverse Events [Device Safety]

Secondary outcome measures

Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)

Range of Motion, Articular

Restore System Feasibility during Rehabilitation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Immediate Start Vagus Nerve Stimulation groupExperimental Treatment1 Intervention

The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately 6 weeks during phase 1. For phase 2, all subjects will be provided the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. Participants that elect to continue in the open-label extension will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.

Group II: Delayed Start Vagus Nerve Stimulation groupPlacebo Group1 Intervention

The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation for 18 in-office sessions over the course of approximately 6 weeks during phase 1. For phase 2, all subjects will be provided the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. Participants that elect to continue in the open-label extension will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Baylor Research InstituteLead Sponsor

200 Previous Clinical Trials

203,206 Total Patients Enrolled

Wings for LifeOTHER

6 Previous Clinical Trials

833 Total Patients Enrolled

Defense Advanced Research Projects AgencyFED

18 Previous Clinical Trials

78,903 Total Patients Enrolled

Media Library

Targeted Plasticity Therapy (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT04288245 — N/A

Spinal Cord Injury Research Study Groups: Immediate Start Vagus Nerve Stimulation group, Delayed Start Vagus Nerve Stimulation group

Spinal Cord Injury Clinical Trial 2023: Targeted Plasticity Therapy Highlights & Side Effects. Trial Name: NCT04288245 — N/A

Targeted Plasticity Therapy (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04288245 — N/A

Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04288245 — N/A

Frequently Asked Questions

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

Are elderly citizens qualified for this clinical trial?

"This trial is only for patients aged 18-64. There are 154 other clinical trials for patients that are younger and 823 for patients that are older."

Answered by AI

If a patient meets the requirements, can they enroll in the trial today?

"The clinical trial in question, which was first announced on February 15th 2021, is not currently seeking patients. This is according to the most recent update on clinicaltrials.gov from May 18th, 2022. There are, however, 1002 other medical studies that are actively recruiting patients."

Answered by AI