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
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in corticospinal excitability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Anti-hypertensive drugs (Carbidopa and L-DOPA)
- •Iron salts
- •Metoclopramide
- •Phenothiazine medication
研究组 & 干预措施
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.
干预措施: Carbidopa (Drug)
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.
干预措施: Placebo oral tablet (Drug)
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.
干预措施: 5HTP (Drug)
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.
干预措施: L-DOPA (Drug)
结局指标
主要结局
Change in corticospinal excitability
时间窗: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Transcranial magnetic stimulation motor-evoked potentials
Change in motoneuron excitability
时间窗: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
F waves
Change in spasticity
时间窗: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Cutaneomuscular reflex
Change in spinal excitability
时间窗: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
H reflex
Change in movement performance
时间窗: Pre drug-intake, 120-150minutes post drug-intake
Leg cycling
次要结局
- Serum Analysis 5-HT(90-120minutes post drug-intake)
- Serum Catechloamines(90-120minutes post drug-intake)
- Urine Homovanillic acid(90-120minutes post drug-intake)
- Serum Analysis 5-HIAA(90-120minutes post drug-intake)
- Whole blood analysis 5-HT(90-120minutes post drug-intake)
- Serum analysis Cortisol(90-120minutes post drug-intake)
- Serum and Urine Analysis of dopamine(90-120min post drug-intake)
研究者
Jessica M D'Amico
Assistant Professor
University of Louisville