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Behavioural Intervention

FES Exercise + NIV/Buspirone for Spinal Cord Injury

Phase 2

Recruiting

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

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

Must have

ASIA Scale A, B, or C injury at or above neurological level T4

SCI outpatients aged 18-45 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Awards & highlights

Study Summary

This trial will investigate two potential methods of improving ventilation in those with high-level SCI in order to enhance their aerobic capacity while engaging in a 6-month FES row training program.

Who is the study for?

This trial is for medically stable adults aged 18-45 with a high-level spinal cord injury (SCI), specifically ASIA Scale A, B, or C at or above T4. Participants should be 3 months to 6 years post-injury, able to follow directions, use a wheelchair and have leg muscles responsive to stimulation. Exclusions include hypertension, tobacco use, epilepsy, other neurological diseases, renal disease, cancer, certain medication usage including buspirone and MAO inhibitors.Check my eligibility

What is being tested?

The study tests two methods to improve breathing in people with high-level SCI during a 6-month Functional Electrical Stimulation Row Training program: Noninvasive Ventilation (NIV) which is an external breathing support machine; and Buspar (Buspirone Hydrochloride), a drug potentially beneficial for respiratory dysfunction after SCI. Participants will receive either NIV or sham ventilation along with Buspar or placebo.See study design

What are the potential side effects?

Potential side effects of the interventions may include discomfort from the non-invasive ventilation equipment and possible reactions to Buspar such as dizziness, nausea, headache or restlessness. The electrical stimulation could cause skin irritation where electrodes are placed.

Eligibility Criteria

Inclusion Criteria

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

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My spinal cord injury is severe and above my chest.

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I am between 18 and 45 years old and have a spinal cord injury.

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I use a wheelchair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in baseline aerobic exercise capacity

Change in baseline ventilation during exercise

Secondary outcome measures

Change from baseline in glucoregulatory status

Change from baseline in serum lipids

Change from baseline in visceral adiposity

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: NIV + BusparExperimental Treatment3 Interventions

Subjects will perform 6 months of FES-row-training while receiving NIV and taking Buspar.

Group II: sham NIV + placeboActive Control3 Interventions

Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking placebo.

Group III: sham NIV + BusparPlacebo Group3 Interventions

Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking Buspar.

Group IV: NIV + placeboPlacebo Group3 Interventions

Subjects will perform 6 months of FES-row-training while receiving NIV and taking placebo.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

135 Previous Clinical Trials

10,985 Total Patients Enrolled

Media Library

Functional Electrical Stimulation Row Training (FESRT) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04458324 — Phase 2

Spinal Cord Injury Research Study Groups: sham NIV + placebo, sham NIV + Buspar, NIV + Buspar, NIV + placebo

Spinal Cord Injury Clinical Trial 2023: Functional Electrical Stimulation Row Training (FESRT) Highlights & Side Effects. Trial Name: NCT04458324 — Phase 2

Functional Electrical Stimulation Row Training (FESRT) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458324 — Phase 2

Frequently Asked Questions

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

Are there any enrolling opportunities still available for volunteers?

"The listed clinical trial on clinicaltrials.gov is currently looking for participants. This particular study was first advertised on December 22nd, 2020 with the latest update being on August 4th, 2021."

Answered by AI

How many individuals are being trialed with this medication?

"The clinical trial is currently recruiting patients, as seen on clinicaltrials.gov. This research was originally posted on December 22nd 2020 and the most recent update occurred on August 4th 2021. The study is open to 70 individuals at a single location."

Answered by AI

Does this research include participants who are senior citizens?

"This trial is only for enrollees that are between 18-40 years old. Out of the 921 total studies, 147 were for people under 18 and 774 were for seniors."

Answered by AI

What are some of the risks associated with Noninvasive Ventilation (NIV)?

"Noninvasive Ventilation (NIV) has been given a 2 by our team at Power. This is due to it being in Phase 2 trials, where there is evidence of safety but not efficacy."

Answered by AI

Does this research builds off of prior investigations into NIV?

"So far, there have been 11 completed or ongoing studies for Noninvasive Ventilation (NIV), with none in Phase 3. Additionally, although several of the trials are being conducted in Tianjin, other cities conducting research on NIV include11 locations running studies for Noninvasive Ventilation (NIV)."

Answered by AI

Which patients fit the screening criteria for this experimental treatment?

"The ideal participants for this study are individuals with a spinal cord injury that is between 18 and 40 years old, have a body mass index of 18.5 to 30 kg/m2. To be eligible, they must also 3 to 24 months post-injury, ASIA Scale A, B, or C injury at or above neurological level T4 , able to follow directions, wheelchair users, and finally have leg muscles responsive to stimulation."

Answered by AI

What hope does this research offer patients and families?

"The primary objectives of this study, which will be evaluated at Baseline, 3 months, and 6 months, is to Change in baseline ventilation during exercise. Additionally, the researchers hope to observe a change from baseline in glucoregulatory status ( Blood will be taken via standard venipuncture to measure hemoglobin A1c.), as well as a change from baseline in serum lipids ( Blood will be taken via standard venipuncture to measure triglycerides.) and finally, a change in baseline maximal voluntary ventilation (Spirometry will be used to measure lung function, specifically maximal voluntary ventilation (MVV))."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury

J. Andrew Taylor 2020. "Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04458324.

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