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

NCT04458324 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 2020P001363
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. However, despite the potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via hybrid FES exercise, the inability to increase ventilation beyond limits set by high level SCI restricts aerobic capacity. This research study will investigate two potential methods of improving ventilation in those with high-level SCI through a double-blind randomized trial. One method is non-invasive ventilation (NIV), which is an external breathing support machine. The second method is the use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats and some human case reports. In this study, participants will engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate cardiopulmonary health and fitness.

Conditions

Spinal Cord Injuries

Keywords

Function Electrical Stimulation (FES)-Rowing

Outcome Measures

Primary Outcomes (2)

• Change in baseline aerobic exercise capacity

  Participants perform incremental FES rowing exercise test to determine maximum oxygen consumption (VO2 peak)

  Baseline, 3 months, 6 months

• Change in baseline ventilation during exercise

  Participants perform incremental FES rowing exercise test to determine ventilation during exercise (VE peak).

  Baseline, 3 months, 6 months

Secondary Outcomes (11)

• Change from baseline in glucoregulatory status

  Baseline, 3 months, 6 months

• Change from baseline in glucoregulatory status

  Baseline, 3 months, 6 months

• Change from baseline in glucoregulatory status

  Baseline, 3 months, 6 months

• Change from baseline in serum lipids

  Baseline, 3 months, 6 months

• Change from baseline in serum lipids

  Baseline, 3 months, 6 months

Study Arms (4)

NIV + Buspar

EXPERIMENTAL

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

Drug: Buspirone Hydrochloride; Device: Noninvasive Ventilation (NIV); Other: Functional Electrical Stimulation Row Training (FESRT)

NIV + placebo

PLACEBO COMPARATOR

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

Drug: Buspirone placebo; Device: Noninvasive Ventilation (NIV); Other: Functional Electrical Stimulation Row Training (FESRT)

sham NIV + Buspar

SHAM COMPARATOR

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

Drug: Buspirone Hydrochloride; Device: Sham Non-invasive ventilation (NIV); Other: Functional Electrical Stimulation Row Training (FESRT)

sham NIV + placebo

ACTIVE COMPARATOR

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

Drug: Buspirone placebo; Device: Sham Non-invasive ventilation (NIV); Other: Functional Electrical Stimulation Row Training (FESRT)

Interventions

Buspirone Hydrochloride DRUG

Subjects take 30 mg buspirone HCl twice a day for 6 months.

Also known as: Buspar

NIV + Buspar; sham NIV + Buspar

Buspirone placebo DRUG

Subjects take a placebo tablet twice a day for 6 months.

NIV + placebo; sham NIV + placebo

Noninvasive Ventilation (NIV) DEVICE

The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.

NIV + Buspar; NIV + placebo

Sham Non-invasive ventilation (NIV) DEVICE

The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.

sham NIV + Buspar; sham NIV + placebo

Functional Electrical Stimulation Row Training (FESRT) OTHER

Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.

NIV + Buspar; NIV + placebo; sham NIV + Buspar; sham NIV + placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• SCI outpatients aged 18-55 years
• medically stable
• body mass index 18.5-30 kg/m2 to include normal to overweight but not obese individuals
• months to 6-years post-injury
• ASIA Scale A, B, or C injury at or above neurological level T4
• able to follow directions
• wheelchair users
• leg muscles responsive to stimulation

You may not qualify if:

• BP \>140/90 mmHg to exclude for hypertension (though rare in those with high level SCI)
• current tobacco users
• significant arrhythmias
• coronary disease
• diabetes
• renal disease
• cancer
• epilepsy
• current use of cardioactive medications (except medication to support blood pressure)
• current grade 2 or greater pressure ulcers at relevant contact sites
• other neurological disease
• peripheral nerve compressions or rotator cuff tears that limit the ability to row
• history of bleeding disorders
• current use of buspirone
• pregnancy

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Buspirone; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Research Lab

Model Details: Subjects are assigned to one of four groups with equal chance: 1. NIV + Buspar, 2. NIV + placebo, 3. sham NIV + Buspar, or 4. sham NIV + placebo

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: December 22, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)