Clinical trial NCT04000919: Effects of 5HTP and LDOPA on CNS Excitability After SCI
Official title: The Effects of 5-hydroxytryptophan (5-HTP) and L-3,4-dihydroxyphenylalanine (L-DOPA) Supplementation on Central Nervous System Excitability and Motor Function in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injuries
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in corticospinal excitability
timeFrame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
measure: Change in motoneuron excitability
timeFrame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
measure: Change in spinal excitability
timeFrame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
measure: Change in spasticity
timeFrame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
measure: Change in movement performance
timeFrame: Pre drug-intake, 120-150minutes post drug-intake
Secondary outcomes:
measure: Serum Analysis 5-HIAA
timeFrame: 90-120minutes post drug-intake
measure: Serum Analysis 5-HT
timeFrame: 90-120minutes post drug-intake
measure: Whole blood analysis 5-HT
timeFrame: 90-120minutes post drug-intake
measure: Serum analysis Cortisol
timeFrame: 90-120minutes post drug-intake
measure: Serum and Urine Analysis of dopamine
timeFrame: 90-120min post drug-intake
measure: Serum Catechloamines
timeFrame: 90-120minutes post drug-intake
measure: Urine Homovanillic acid
timeFrame: 90-120minutes post drug-intake
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville, Kentucky Spinal Cord Injury Research Centre
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Jessica D'Amico, PhD
role: PRINCIPAL_INVESTIGATOR
References: