Effects of 5HTP and LDOPA on CNS Excitability After SCI

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jessica D'Amico; Jessica M D'Amico
• Treatments: 5-Hydroxytryptophan; Carbidopa; Dihydroxyphenylalanine; Levodopa

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