Spinal Cord Injuries
Conditions
Brief summary
This study will examine whether supplementation with the serotonin and dopamine precursors, 5HTP and L-DOPA can alter central nervous system excitability and improve motor function after incomplete and complete spinal cord injuries.
Interventions
Sponsors
Jessica M D'Amico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both the participant and assessors are blinded to which drug/placebo the participant reviews because all drugs are housed in similar capsules. Only the PI and caregiver will be aware of which drug will be administered for safety purposes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Individuals aged 18-65 years of age. * Patients must have suffered a trauma to the spinal cord at least 1 year ago or longer. * Patients must exhibit some degree of spasticity which can be self-reported (Penn spasm frequency) or if assessed by a physiotherapist, a modified Ashworth spasticity score greater than 1
Exclusion criteria
* Individuals with damage to the nervous system other than to the spinal cord * Pregnant or breastfeeding women * Alcoholic patients * Patients with a history of seizures or epilepsy * Patients with a history of suicidal thoughts or behaviors * Patients with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps * Patients with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head * Patients with: * Known or suspected allergy to the medication or the ingredients * Cardiovascular disease including history of heart attack or heart rhythm irregularities * Coronary artery disease * Comatose or depressed states due to CNS depressants * Endocrine dysfunction * Blood dyscrasias * Bone marrow depression * History of seizures * Hypocalcemia * History of stomach ulcers * Wide-angle glaucoma * Phenylketonuria Patients taking: * Monoamine oxidase inhibitor therapy * Serotonergic antidepressants: selective serotonin and norepinephrine reuptake inhibitors * Tricyclic antidepressants * Any type of serotonergic agonist * Dopamine D2 receptor antagonists * Amphetamine * CNS depressants * Levodopa * Lithium * Anti-hypertensive drugs (Carbidopa and L-DOPA) * Iron salts * Metoclopramide * Phenothiazine medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in corticospinal excitability | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake | Transcranial magnetic stimulation motor-evoked potentials |
| Change in motoneuron excitability | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake | F waves |
| Change in spinal excitability | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake | H reflex |
| Change in spasticity | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake | Cutaneomuscular reflex |
| Change in movement performance | Pre drug-intake, 120-150minutes post drug-intake | Leg cycling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Catechloamines | 90-120minutes post drug-intake | catecholamines and homovanillic acid (urine) |
| Serum Analysis 5-HIAA | 90-120minutes post drug-intake | 5-HIAA (serum) |
| Urine Homovanillic acid | 90-120minutes post drug-intake | homovanillic acid (urine) |
| Serum Analysis 5-HT | 90-120minutes post drug-intake | 5-HT (serum) |
| Whole blood analysis 5-HT | 90-120minutes post drug-intake | 5-HT (whole blood) |
| Serum analysis Cortisol | 90-120minutes post drug-intake | Cortisol level |
| Serum and Urine Analysis of dopamine | 90-120min post drug-intake | catecholamines and homovanillic acid (urine) |
Countries
United States
Outcome results
None listed