Trial Outcomes & Findings for Improving Ventilatory Capacity in Those With Chronic High Level SCI (NCT NCT05041322)

NCT ID: NCT05041322

Last Updated: 2025-09-18

Results Overview

Forced expiratory volume over 1 second (FEV1).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 14 Days
• Results posted on: 2025-09-18

Participant Flow

Individuals with a medically stable spinal cord injury at neurological level >T3 and AIS A, B, or C were recruited 2021-22 to participate in the study.

Excluded if they have cardiovascular disease, diabetes, other neurological disease, renal disease, or cancer. Also excluded with current use of tobacco, cardioactive medications, antidepressants, or sedating agents.

Participant milestones

Measure	Placebo Then Buspirone If eligible, all participants were studied at baseline before being randomly assigned to a 14 days of treatment (placebo or busrpirone) before crossing over to the other arm.	Buspirone Then Placebo If eligible, all participants were studied at baseline before being randomly assigned to a 14 days of treatment (placebo or busrpirone) before crossing over to the other arm.
Baseline STARTED	5	4
Baseline COMPLETED	4	4
Baseline NOT COMPLETED	1	0
Treatment 1 (14 Days) STARTED	4	4
Treatment 1 (14 Days) COMPLETED	2	3
Treatment 1 (14 Days) NOT COMPLETED	2	1
Treatment 2 (14 Days) STARTED	2	3
Treatment 2 (14 Days) COMPLETED	2	3
Treatment 2 (14 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Placebo Then Buspirone If eligible, all participants were studied at baseline before being randomly assigned to a 14 days of treatment (placebo or busrpirone) before crossing over to the other arm.	Buspirone Then Placebo If eligible, all participants were studied at baseline before being randomly assigned to a 14 days of treatment (placebo or busrpirone) before crossing over to the other arm.
Baseline Withdrawal by Subject	1	0
Treatment 1 (14 Days) Adverse Event	1	0
Treatment 1 (14 Days) Withdrawal by Subject	1	1

Baseline Characteristics

Equipment failure led to one sleep study not being recorded.

Baseline characteristics by cohort

Measure	All Participants n=8 Participants If eligible, all participants were studied at baseline before being randomly assigned to a 14 days of treatment (placebo or busrpirone) before crossing over to the other arm.
Age, Continuous	33.1 Years STANDARD_DEVIATION 8.54 • n=8 Participants
Sex: Female, Male Female	0 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=8 Participants
Race (NIH/OMB) White	7 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants
Pulmonary Function	3.15 L STANDARD_DEVIATION 1.06 • n=8 Participants
Hypercapnic Ventilatory Response	0.725 L /min/mmHg of CO2 STANDARD_DEVIATION 0.525 • n=8 Participants
Sleep Quality	2.85 apneas + hypopneas per hour STANDARD_DEVIATION 7.01 • n=7 Participants • Equipment failure led to one sleep study not being recorded.
Exercise Pulmonary Capacity	15.32 ml/kg of O2 STANDARD_DEVIATION 7.01 • n=7 Participants • One participant did not reach VO2max, so is not included.

PRIMARY outcome

Timeframe: 14 Days

Forced expiratory volume over 1 second (FEV1).

Outcome measures

Measure	Placebo n=5 Participants Subjects take placebo pills (twice a day) for 14 Days.	Buspirone n=5 Participants Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days. Other Names: Buspar
Pulmonary Function	3.59 L Standard Deviation 1.07	3.77 L Standard Deviation 1.12

PRIMARY outcome

Timeframe: 14 Days

A change in the drive to breathe with a change in carbon dioxide

Outcome measures

Measure	Placebo n=5 Participants Subjects take placebo pills (twice a day) for 14 Days.	Buspirone n=5 Participants Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days. Other Names: Buspar
Hypercapnic Ventilatory Response	0.659 L /min/mmHg of CO2 Standard Deviation 0.320	0.566 L /min/mmHg of CO2 Standard Deviation 0.133

PRIMARY outcome

Timeframe: 14 Days

Sleep apneas and hypopneas per hour.

Outcome measures

Measure	Placebo n=5 Participants Subjects take placebo pills (twice a day) for 14 Days.	Buspirone n=5 Participants Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days. Other Names: Buspar
Sleep Quality	4.26 counts per hour Standard Deviation 2.11	6.18 counts per hour Standard Deviation 2.97

PRIMARY outcome

Timeframe: 14 Days

Change in peak oxygen consumption during exercise

Outcome measures

Measure	Placebo n=5 Participants Subjects take placebo pills (twice a day) for 14 Days.	Buspirone n=5 Participants Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days. Other Names: Buspar
Exercise Pulmonary Capacity	18.28 ml/kg of O2 Standard Deviation 8.20	17.69 ml/kg of O2 Standard Deviation 7.29

Adverse Events

Buspirone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Buspirone n=5 participants at risk Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days. Other Names: Buspar	Placebo n=6 participants at risk Subjects take placebo pills (twice a day) for 14 Days.
Gastrointestinal disorders Gastrointestinal distress	0.00% 0/5 • From enrollment to end of second treatment, up to 28 days.	16.7% 1/6 • From enrollment to end of second treatment, up to 28 days.

Additional Information

Jason Hamner

Spaulding Hospital Cambridge

Phone: 6177585501

Email: jhamner@mgb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place