Spinal Cord Injuries Clinical Trial
Official title:
Improving Ventilatory Capacity in Those With Chronic High Level SCI
The purpose of this study is to find out if taking the drug Buspar will increase breathing capacity in individuals with spinal cord injuries.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | November 29, 2024 |
Est. primary completion date | November 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Chronic high-level SCI (at least 24-months post injury) - Age 18 to 50 years. - Medically stable - Spinal Cord Injury =T3 - American Spinal Injury Association grade A or B or C. - Able to perform arm crank exercise. Exclusion Criteria: - Cardiomyopathy - High blood pressure( >140/90 mmHg or you are taking high blood pressure medication) - Significant irregular heartbeat - Heart disease - Chronic lung disease (COPD, bronchitis) - Current use of cardioactive or antidepressant drugs - Family history of significant irregular heart beat or sudden cardiac death - Orthostatic hypotension (symptomatic fall in blood pressure >30 mmHg when upright) - Current grade 2 or greater pressure ulcers at relevant contact site - Neurological disease (stroke, peripheral neuropathy, myopathy) - Arm or shoulder conditions that limit ability to perform arm crank exercise - History of bleeding disorder, diabetes, kidney disease, cancer, other neurological disease - Recent weigh change (greater than 10 pounds) - Regular use of tobacco - Intrathecal baclofen pump, - Current use of cardioactive, antidepressant, other sedating agents - Suicidal ideation - Pregnant and/or breastfeeding women. In addition, subjects must have no known hypersensitivity to Buspar and must not be taking a monoamine oxidase inhibitor. |
Country | Name | City | State |
---|---|---|---|
United States | Spaulding Hospital Cambridge | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Spaulding Rehabilitation Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary Function | A change in FEV1 | 14 Days | |
Primary | Hypercapnic Ventilatory Response | A change in the drive to breathe with a change in carbon dioxide | 14 Days | |
Primary | Sleep Quality | A change in sleep apneas | 14 Days | |
Primary | Exercise Pulmonary Capacity | Change in peak oxygen consumption during exercise | 14 Days |
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