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Effects of 5HTP and LDOPA on CNS Excitability After SCI

Sponsor
Jessica M D'Amico (Other)
Overall Status
Recruiting
CT.gov ID
NCT04000919
Collaborator
(none)
30
Enrollment
1
Location
4
Arms
54.4
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, 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.
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Jun 19, 2019
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Effects of single-dose of carbidopa (50mg) on CNS excitability

Participants will visit the lab and on one of four different occasions they will receive carbidopa only (50 mg). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.

Drug: Carbidopa
Carbidopa (50mg)
Placebo Comparator: Effects of single-dose placebo on CNS Excitability

Participants will visit the lab and on one of four different occasions and will receive a placebo. Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.

Drug: Placebo oral tablet
Placebo
Active Comparator: Effects of single-dose 5HTP/carbidopa on CNS Excitability

During one of the four occasions participants visit the lab they will receive 5HTP combined with carbidopa (50-200mg HTP/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.

Drug: 5HTP
5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
Other Names:
  • carbidopa

    		•
    Active Comparator: Effects of single-dose L-DOPA/carbidopa on CNS Excitability

    During one of the four occasions participants visit the lab they will receive L-DOPA combined with carbidopa (50-200mg L-DOPA/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.

    Drug: L-DOPA
    L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
    Other Names:
  • Sinemet
  • Carbidopa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in corticospinal excitability [Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake]

      Transcranial magnetic stimulation motor-evoked potentials

    2. Change in motoneuron excitability [Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake]

      F waves

    3. Change in spinal excitability [Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake]

      H reflex

    4. Change in spasticity [Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake]

      Cutaneomuscular reflex

    5. Change in movement performance [Pre drug-intake, 120-150minutes post drug-intake]

      Leg cycling

    Secondary Outcome Measures

    1. Serum Analysis 5-HIAA [90-120minutes post drug-intake]

      5-HIAA (serum)

    2. Serum Analysis 5-HT [90-120minutes post drug-intake]

      5-HT (serum)

    3. Whole blood analysis 5-HT [90-120minutes post drug-intake]

      5-HT (whole blood)

    4. Serum analysis Cortisol [90-120minutes post drug-intake]

      Cortisol level

    5. Serum and Urine Analysis of dopamine [90-120min post drug-intake]

      catecholamines and homovanillic acid (urine)

    6. Serum Catechloamines [90-120minutes post drug-intake]

      catecholamines and homovanillic acid (urine)

    7. Urine Homovanillic acid [90-120minutes post drug-intake]

      homovanillic acid (urine)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Louisville, Kentucky Spinal Cord Injury Research Centre Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • Jessica M D'Amico

    Investigators

    • Principal Investigator: Jessica D'Amico, PhD, University of Louisville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jessica M D'Amico, Assistant Professor, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT04000919
    Other Study ID Numbers:
    • 18.1268
    First Posted:
    Jun 27, 2019
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Carbidopa

    Study Results

    No Results Posted as of Aug 30, 2021