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Effects of 5HTP and LDOPA on CNS Excitability After SCI

Primary Purpose

Spinal Cord Injuries

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5HTP
L-DOPA
Placebo oral tablet
Carbidopa
Sponsored by
Jessica M D'Amico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville, Kentucky Spinal Cord Injury Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Effects of single-dose of carbidopa (50mg) on CNS excitability

Effects of single-dose placebo on CNS Excitability

Effects of single-dose 5HTP/carbidopa on CNS Excitability

Effects of single-dose L-DOPA/carbidopa on CNS Excitability

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in corticospinal excitability
Transcranial magnetic stimulation motor-evoked potentials
Change in motoneuron excitability
F waves
Change in spinal excitability
H reflex
Change in spasticity
Cutaneomuscular reflex
Change in movement performance
Leg cycling

Secondary Outcome Measures

Serum Analysis 5-HIAA
5-HIAA (serum)
Serum Analysis 5-HT
5-HT (serum)
Whole blood analysis 5-HT
5-HT (whole blood)
Serum analysis Cortisol
Cortisol level
Serum and Urine Analysis of dopamine
catecholamines and homovanillic acid (urine)
Serum Catechloamines
catecholamines and homovanillic acid (urine)
Urine Homovanillic acid
homovanillic acid (urine)

Full Information

First Posted
June 19, 2019
Last Updated
October 13, 2022
Sponsor
Jessica M D'Amico
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1. Study Identification

Unique Protocol Identification Number
NCT04000919
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
PI left UofL and intends to reopen study at University of Alberta
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jessica M D'Amico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effects of single-dose of carbidopa (50mg) on CNS excitability
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Effects of single-dose placebo on CNS Excitability
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Effects of single-dose 5HTP/carbidopa on CNS Excitability
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Effects of single-dose L-DOPA/carbidopa on CNS Excitability
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
5HTP
Other Intervention Name(s)
carbidopa
Intervention Description
5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
Intervention Type
Drug
Intervention Name(s)
L-DOPA
Other Intervention Name(s)
Sinemet, Carbidopa
Intervention Description
L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Carbidopa
Intervention Description
Carbidopa (50mg)
Primary Outcome Measure Information:
Title
Change in corticospinal excitability
Description
Transcranial magnetic stimulation motor-evoked potentials
Time Frame
Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Title
Change in motoneuron excitability
Description
F waves
Time Frame
Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Title
Change in spinal excitability
Description
H reflex
Time Frame
Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Title
Change in spasticity
Description
Cutaneomuscular reflex
Time Frame
Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Title
Change in movement performance
Description
Leg cycling
Time Frame
Pre drug-intake, 120-150minutes post drug-intake
Secondary Outcome Measure Information:
Title
Serum Analysis 5-HIAA
Description
5-HIAA (serum)
Time Frame
90-120minutes post drug-intake
Title
Serum Analysis 5-HT
Description
5-HT (serum)
Time Frame
90-120minutes post drug-intake
Title
Whole blood analysis 5-HT
Description
5-HT (whole blood)
Time Frame
90-120minutes post drug-intake
Title
Serum analysis Cortisol
Description
Cortisol level
Time Frame
90-120minutes post drug-intake
Title
Serum and Urine Analysis of dopamine
Description
catecholamines and homovanillic acid (urine)
Time Frame
90-120min post drug-intake
Title
Serum Catechloamines
Description
catecholamines and homovanillic acid (urine)
Time Frame
90-120minutes post drug-intake
Title
Urine Homovanillic acid
Description
homovanillic acid (urine)
Time Frame
90-120minutes post drug-intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica D'Amico, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville, Kentucky Spinal Cord Injury Research Centre
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of 5HTP and LDOPA on CNS Excitability After SCI

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