Spinal Cord InjuriesPhase 2NCT04458324
Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury
A Phase 2 study testing Buspirone Hydrochloride, Noninvasive Ventilation (NIV) and Functional Electrical Stimulation Row Training (FESRT) in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Buspirone Hydrochloride, Noninvasive Ventilation (NIV) and Functional Electrical Stimulation Row Training (FESRT)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 15 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
About this study
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.
Read the detailed description
Regular aerobic exercise with sufficient intensity can improve overall health, however daily energy expenditure is low in those with SCI, especially in those with high level lesions. The investigators have developed Functional Electrical Stimulation Row Training (FESRT) that couples volitional arm and electrically controlled leg exercise, increasing the active muscle and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing aerobic capacity, those with high level lesions (T3 and above) have a remaining obstacle to attaining higher work capacities: a level of pulmonary muscle denervation. The investigators preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT.
External ventilatory support could improve the ability to exercise train and hence enhance the adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during exercise training has been shown to improve gains in exercise capacity in those with similarly restrictive breathing. Therefore, the investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic capacity in high level SCI. In addition, pharmacologic treatments may augment respiratory control and improve exercise ventilatory responses. Buspirone can reverse respiratory abnormalities consequent to SCI in rats, and humans case reports suggest successful Buspirone treatment of respiratory dysfunction
Therefore, the investigators propose a double-blind 2x2 trial of 6 months of FESRT with NIV or Sham and Buspirone or Placebo in individuals with acute, high-level SCI. The investigators hypothesize that both NIV and Buspirone will improve ventilatory exercise responses and that combined treatment will have the greatest effect. This will result in greater improvements in aerobic capacity and concomitant increases in pulmonary function and reductions in cardiometabolic risk. This work proposes two approaches to overcome ventilatory limitations to exercise in high level SCI and allow for greater improvements in cardiopulmonary capacity - one that overcomes mechanical limitations of paralyzed pulmonary musculature and one that treats loss of serotonergic respiratory control, both of which may contribute to blunted ventilatory responses. The ultimate purpose of this research is to optimize exercise for a population that both needs and seeks the broad range of benefits that exercise can confer.
- Conditions
- Spinal Cord Injuries
- Being tested
- Buspirone Hydrochloride, Buspirone placebo, Noninvasive Ventilation (NIV), Sham Non-invasive ventilation (NIV), Functional Electrical Stimulation Row Training (FESRT)
- Keywords
- Function Electrical Stimulation (FES)-Rowing
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buspirone HydrochlorideDrug
Also called Buspar
Subjects take 30 mg buspirone HCl twice a day for 6 months.
Buspirone placeboDrug
Subjects take a placebo tablet twice a day for 6 months.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| NIV + Buspar | Experimental | Subjects will perform 6 months of FES-row-training while receiving NIV and taking Buspar. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Buspirone placebo; Device: Sham Non-invasive ventilation (NIV); Other: Functional Electrical Stimulation Row Training (FESRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline aerobic exercise capacity
Participants perform incremental FES rowing exercise test to determine maximum oxygen consumption (VO2 peak)
Measured: 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).
Measured: Baseline, 3 months, 6 months
Secondary outcomes (11)
Change from baseline in glucoregulatory status
Blood will be taken via standard venipuncture to measure the homeostasis model assessment (HOMA) of insulin resistance.
Measured: Baseline, 3 months, 6 months
Change from baseline in glucoregulatory status
Blood will be taken via standard venipuncture to measure the quantitative insulin check index (QUICKI).
Measured: Baseline, 3 months, 6 months
Change from baseline in glucoregulatory status
Blood will be taken via standard venipuncture to measure hemoglobin A1c.
Measured: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Blood will be taken via standard venipuncture to measure plasma total cholesterol.
Measured: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Blood will be taken via standard venipuncture to measure low-density lipoprotein cholesterol.
Measured: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Blood will be taken via standard venipuncture to measure high density apolipoprotein cholesterol.
Measured: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Blood will be taken via standard venipuncture to measure triglycerides.
Measured: Baseline, 3 months, 6 months
Change from baseline in visceral adiposity
The investigators will use a 5th generation General Electric Healthcare dual x-ray absorptiometry (DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study.
Measured: Baseline, 3 months, 6 months
Change in baseline forced vital capacity
Spirometry will be used to measure lung function, specifically forced vital capacity (FVC).
Measured: Baseline, 3 months, 6 months
Change in baseline maximal voluntary ventilation
Spirometry will be used to measure lung function, specifically maximal voluntary ventilation (MVV).
Measured: Baseline, 3 months, 6 months
Change in baseline forced expiratory capacity in the first second
Spirometry will be used to measure lung function, specifically forced expiratory capacity in the first second (FEV1).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start22 Dec 2020
- Primary completion15 Apr 2026
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Andrew Taylor, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458324
- Sponsor's protocol ID
- 2020P001363
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04458324
- Acronym / sponsor ID
- 2020P001363
- Conditions
- Spinal Cord Injuries
- Keywords
- Function Electrical Stimulation (FES)-Rowing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Regular aerobic exercise with sufficient intensity can improve overall health, however daily energy expenditure is low in those with SCI, especially in those with high level lesions. The investigators have developed Functional Electrical Stimulation Row Training (FESRT) that couples volitional arm and electrically controlled leg exercise, increasing the active muscle and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing aerobic capacity, those with high level lesions (T3 and above) have a remaining obstacle to attaining higher work capacities: a level of pulmonary muscle denervation. The investigators preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT.
External ventilatory support could improve the ability to exercise train and hence enhance the adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during exercise training has been shown to improve gains in exercise capacity in those with similarly restrictive breathing. Therefore, the investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic capacity in high level SCI. In addition, pharmacologic treatments may augment respiratory control and improve exercise ventilatory responses. Buspirone can reverse respiratory abnormalities consequent to SCI in rats, and humans case reports suggest successful Buspirone treatment of respiratory dysfunction
Therefore, the investigators propose a double-blind 2x2 trial of 6 months of FESRT with NIV or Sham and Buspirone or Placebo in individuals with acute, high-level SCI. The investigators hypothesize that both NIV and Buspirone will improve ventilatory exercise responses and that combined treatment will have the greatest effect. This will result in greater improvements in aerobic capacity and concomitant increases in pulmonary function and reductions in cardiometabolic risk. This work proposes two approaches to overcome ventilatory limitations to exercise in high level SCI and allow for greater improvements in cardiopulmonary capacity - one that overcomes mechanical limitations of paralyzed pulmonary musculature and one that treats loss of serotonergic respiratory control, both of which may contribute to blunted ventilatory responses. The ultimate purpose of this research is to optimize exercise for a population that both needs and seeks the broad range of benefits that exercise can confer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| NIV + Buspar | Experimental | Drug: Buspirone Hydrochloride, Device: Noninvasive Ventilation (NIV), Other: Functional Electrical Stimulation Row Training (FESRT)Subjects will perform 6 months of FES-row-training while receiving NIV and taking Buspar. |
| NIV + placebo | Placebo comparator | Drug: Buspirone placebo, Device: Noninvasive Ventilation (NIV), Other: Functional Electrical Stimulation Row Training (FESRT)Subjects will perform 6 months of FES-row-training while receiving NIV and taking placebo. |
| sham NIV + Buspar | Sham comparator | Drug: Buspirone Hydrochloride, Device: Sham Non-invasive ventilation (NIV), Other: Functional Electrical Stimulation Row Training (FESRT)Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking Buspar. |
| sham NIV + placebo | Active comparator | Drug: Buspirone placebo, Device: Sham Non-invasive ventilation (NIV), Other: Functional Electrical Stimulation Row Training (FESRT)Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- BP >140/90 mmHg to exclude for hypertension (though rare in those with high level SCI)
- current tobacco users
- significant arrhythmias
- coronary disease
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buspirone HydrochlorideAlso: BusparSubjects take 30 mg buspirone HCl twice a day for 6 months. | Drug | NIV + Buspar, sham NIV + Buspar |
| Buspirone placeboSubjects take a placebo tablet twice a day for 6 months. | Drug | NIV + placebo, sham NIV + placebo |
| Noninvasive Ventilation (NIV)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. | Device | NIV + Buspar, NIV + placebo |
| Sham Non-invasive ventilation (NIV)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. | Device | sham NIV + Buspar, sham NIV + placebo |
| Functional Electrical Stimulation Row Training (FESRT)Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES. | Other | NIV + Buspar, NIV + placebo, sham NIV + Buspar, sham NIV + placebo |
Primary outcome
Change in baseline aerobic exercise capacity
Time frame: Baseline, 3 months, 6 months
Participants perform incremental FES rowing exercise test to determine maximum oxygen consumption (VO2 peak)
Change in baseline ventilation during exercise
Time frame: Baseline, 3 months, 6 months
Participants perform incremental FES rowing exercise test to determine ventilation during exercise (VE peak).
11 secondary outcomes
Change from baseline in glucoregulatory status
Time frame: Baseline, 3 months, 6 months
Change from baseline in glucoregulatory status
Time frame: Baseline, 3 months, 6 months
Change from baseline in glucoregulatory status
Time frame: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Time frame: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Time frame: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Time frame: Baseline, 3 months, 6 months
Change from baseline in serum lipids
Time frame: Baseline, 3 months, 6 months
Change from baseline in visceral adiposity
Time frame: Baseline, 3 months, 6 months
Change in baseline forced vital capacity
Time frame: Baseline, 3 months, 6 months
Change in baseline maximal voluntary ventilation
Time frame: Baseline, 3 months, 6 months
Change in baseline forced expiratory capacity in the first second
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buspirone Hydrochloride, Noninvasive Ventilation (NIV) and Functional Electrical Stimulation Row Training (FESRT) in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline aerobic exercise capacity (time frame: Baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.