Effects of 5HTP and LDOPA on CNS Excitability After SCI

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04000919
• Other study ID #: 18.1268
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: June 19, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Drug:
• 5HTP
5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
• L-DOPA
L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
• Placebo oral tablet
Placebo
• Carbidopa
Carbidopa (50mg)

Locations

Country	Name	City	State
United States	University of Louisville, Kentucky Spinal Cord Injury Research Centre	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Jessica M D'Amico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in corticospinal excitability	Transcranial magnetic stimulation motor-evoked potentials	Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Primary	Change in motoneuron excitability	F waves	Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Primary	Change in spinal excitability	H reflex	Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Primary	Change in spasticity	Cutaneomuscular reflex	Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Primary	Change in movement performance	Leg cycling	Pre drug-intake, 120-150minutes post drug-intake
Secondary	Serum Analysis 5-HIAA	5-HIAA (serum)	90-120minutes post drug-intake
Secondary	Serum Analysis 5-HT	5-HT (serum)	90-120minutes post drug-intake
Secondary	Whole blood analysis 5-HT	5-HT (whole blood)	90-120minutes post drug-intake
Secondary	Serum analysis Cortisol	Cortisol level	90-120minutes post drug-intake
Secondary	Serum and Urine Analysis of dopamine	catecholamines and homovanillic acid (urine)	90-120min post drug-intake
Secondary	Serum Catechloamines	catecholamines and homovanillic acid (urine)	90-120minutes post drug-intake
Secondary	Urine Homovanillic acid	homovanillic acid (urine)	90-120minutes post drug-intake