Effects of 5HTP on spinal cord injuries
Effects of the Serotonin Precursor, 5-hydroxytryptophan, in the Injured Human Spinal Cord
This study is testing if a supplement called 5-HTP can help improve muscle function and nervous system activity in people with spinal cord injuries.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT04520178 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of 5-HTP, a serotonin precursor, on nervous system excitability and motor function in individuals with spinal cord injuries of varying severity and chronicity. Participants will undergo a randomized, double-blinded, placebo-controlled crossover design, receiving four different treatments across four visits. The study aims to understand how 5-HTP, when co-administered with carbidopa to minimize side effects, affects neurophysiological outcomes and functional improvements in muscle activation during cycling. It will include subacute and chronic spinal cord injury patients categorized by their American Spinal Injury Association (ASIA) impairment scale scores.
Who should consider this trial
Good fit: Ideal candidates are individuals who have suffered a spinal cord injury at least six months prior, with varying degrees of injury severity.
Not a fit: Patients with other nervous system damage, significant comorbidities, or those currently on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved motor function and quality of life for patients with spinal cord injuries.
How similar studies have performed: While the use of 5-HTP in this context is novel, previous studies have shown promise in using serotonin precursors for neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Louisville, Kentucky and 1 other locations
- University of Louisville — Louisville, Kentucky, United States (Completed)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Jessica D'Amico, PhD — University of Alberta
- Study coordinator: Jessica D'Amico, PhD
- Email: damico1@ualberta.ca
- Phone: 780-735-7917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.