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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
Must not have
Cancer
Current use of buspirone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer.
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I am currently taking buspirone.
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I am currently taking medication for my heart, excluding blood pressure medication.
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I have severe pressure sores in areas where medical devices touch my skin.
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I have heart disease.
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I have a history of bleeding disorders.
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I have serious heart rhythm problems.
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I don't have allergies to Buspirone, kidney or liver issues, and I'm not on MAO inhibitors or dependent on benzodiazepines.
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I have a neurological condition.
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I have nerve or shoulder issues that prevent me from rowing.
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I have epilepsy.
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I have diabetes.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in baseline aerobic exercise capacity
Change in baseline ventilation during exercise
Secondary study objectives
Change from baseline in glucoregulatory status
Change from baseline in serum lipids
Change from baseline in visceral adiposity
+3 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
139 Previous Clinical Trials
11,018 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
~9 spots leftby Jul 2025
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