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NCT04458324 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Spinal Cord Injuries, sponsored by Spaulding Rehabilitation Hospital.

Active
Registry status
Phase 2
Development phase
70
Enrollment target
1
Study location

NCT04458324 is a Phase 2 study of Spinal Cord Injuries that is active but no longer recruiting, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 70 participants, above the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (15% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04458324, a Phase 2 study of Spinal Cord Injuries, is active but no longer recruiting, sponsored by Spaulding Rehabilitation Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
1
Study location

Study 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 Studied

Spinal Cord Injuries

Interventions

  • DRUG Buspirone Hydrochloride
  • DRUG Buspirone placebo
  • DEVICE Noninvasive Ventilation (NIV)
  • DEVICE Sham Non-invasive ventilation (NIV)
  • OTHER Functional Electrical Stimulation Row Training (FESRT)

Study Locations (1)

Massachusetts

  • Spaulding Hospital Cambridge - Cambridge

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2020-12-22
Est. Completion 2027-07-31
Phase Phase 2

Sponsor

Spaulding Rehabilitation Hospital

101 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04458324

The ClinicalTrials.gov registry entry for NCT04458324 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (15% higher). The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 5 interventions - of which Buspirone Hydrochloride is the first listed.

NCT04458324 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04458324 about?

NCT04458324 is a clinical study titled "Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury". 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 benef...

What is the current status of trial NCT04458324?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2020-12-22. Estimated completion is 2027-07-31.

What conditions does trial NCT04458324 study?

This clinical trial studies the following conditions: Spinal Cord Injuries.

What interventions are being tested in trial NCT04458324?

The interventions under investigation include: Buspirone Hydrochloride (DRUG), Buspirone placebo (DRUG), Noninvasive Ventilation (NIV) (DEVICE), Sham Non-invasive ventilation (NIV) (DEVICE), Functional Electrical Stimulation Row Training (FESRT) (OTHER).

Who is sponsoring clinical trial NCT04458324?

This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04458324 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.