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Can a breathing machine or a drug boost exercise benefits for spinal cord injury?

NCT ID NCT04458324

Disease control Sponsor: Spaulding Rehabilitation Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding non-invasive ventilation (a breathing machine) or the drug Buspar to a special rowing exercise program can improve heart and lung fitness in people with high-level spinal cord injury. Seventy participants will exercise for 6 months while receiving either real or sham breathing support and either Buspar or a placebo. The goal is to see if these additions help increase exercise capacity and ventilation beyond what exercise alone can achieve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Buspirone Hydrochloride (Buspar) and non-invasive ventilation (NIV)
What this could lead to
If it works, this could lead to a way to improve breathing and exercise capacity in people with high-level spinal cord injury, potentially reducing heart and lung complications.
What could go wrong
This is a small, early-phase trial with only 70 participants. The drug and device may not improve breathing enough to make a real difference, and results may not apply to all spinal cord injury patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 3-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 Exclusion Criteria: * 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 * contraindications to Buspirone (taking MAO inhibitors, known hypersensitivity to buspirone, benzodiazepine dependence, akathisia, renal impairment, hepatic disease)

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injuries

Contacts and locations

Locations

  • Spaulding Hospital Cambridge

    Cambridge, Massachusetts, 02138, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.