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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: Active Phase 2 study of Spinal Cord Injuries, sponsored by Spaulding Rehabilitation Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants perform incremental FES rowing exercise test to determine maximum oxygen consumption (VO2 peak)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-12-22 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 2 |
What the registry record for NCT04458324 still lists
NCT04458324 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (15% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04458324's enrollment target sits among peer trials
70 43rd of 202 higher than 159 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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