Spinal Cord Injuries Clinical Trial
— 5-HTP onlyOfficial title:
Effects of the Serotonin Precursor, 5-hydroxytryptophan, in the Injured Human Spinal Cord
This study will assess how the serotonin precursor, 5-HTP, alter nervous system excitability and motor function in individuals with spinal cord injuries of differing chronicity and severity. Participants will visit the lab on 4 separate occasions where they will be administered four different drugs in a randomized, double-blinded, placebo-controlled crossover design.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - participants must have suffered trauma to the spinal cord at least six months ago or longer Exclusion Criteria: - individuals with damage to the nervous system other than to the spinal cord - pregnant and/or breastfeeding women - alcoholic participants - history of seizure/epilepsy - history of suicidal thoughts or behaviors - known or suspected allergy to the medication ingredients - cardiovascular disease including history of heart attack or heart rhythm irregularities - coronary artery disease - reduced liver function or disease - reduced kidney function or disease - lung disease - comatose or depressed states due to CNS depressants - endocrine dysfunction - blood dyscrasias or blood related disease - bone marrow depression - hypocalcemia - history of stomach ulcers - wide angle glaucoma - phenylketonuria - history of tumors - uncontrolled heart problems - unstable psychiatric or mental disorder Participants taking: - monoamine oxidase inhibitor therapy - serotonergic antidepressants - tricyclic antidepressants - any type of serotonergic agonist - dopamine D2 receptor antagonists - amphetamine - CNS depressants - levodopa - lithium - anti-hypertensive drugs - iron salts - metoclopramide - phenothiazine medication |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
United States | University of Louisville | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Wings for Life |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in motoneuron excitability | F waves | Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake | |
Primary | Change in spinal excitability | H reflex | Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake | |
Primary | Change in flexor reflex/spasms | Cutaneomuscular reflex | Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake | |
Primary | Change in functional movement performance | Leg cycling task | Pre drug-intake, 120-150minutes post drug-intake | |
Secondary | Serum analysis of 5HIAA (UofL Cohort only) | 5-HIAA (serum) | 90-120minutes post drug-intake | |
Secondary | Serum analysis of serotonin (UofL Cohort only) | 5-HT (serum and whole blood), cortisol | 90-120minutes post drug-intake | |
Secondary | Serum analysis of cortisol (UofL Cohort only) | serum cortisol | 90-120minutes post drug-intake | |
Secondary | Whole blood analysis of Serotonin (UofL Cohort only) | Blood 5HT | 90-120minutes post drug-intake |
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