Methylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.
研究概览
简要总结
The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD.
The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from treatment initiation in patients with moderately advanced PD, whose gait impairment is an important source of disability despite optimized antiparkinsonian treatment.
详细描述
There are a total of six clinic visits involved in this study. All study-related assessments will take place first during the practically defined off period, that is, in the morning after at least 12 hours from the last dose of any antiparkinsonian medication, followed by a repeat assessment once the "on" state is clearly identified by the patient and examiner (approximately 30 to 60 minutes after taking your Parkinson's medication). This "practically defined off period" state is considered the desired state on which to report motor changes for any currently available or experimental intervention in PD. Patients will be off his or her Parkinson's medication for no more than 14 hours for each of the assessments. Studying patients in the off-period is the most widely used manner in which the value of new therapies can be fully measured.
During the first visit, patients will be "randomized" into one of the study groups described below. Neither the participant nor the researcher conducting this study will choose what group he or she will be in.
Participants will receive either placebo or a dose of 1 mg/kg of Methylphenidate capsules divided into three doses (at 8 am, 12 noon, and 4 pm). An increase in medication over a four week period will be used until a target dosage is reached, which may range from 5 to 8 10-mg capsules per day.
A measure of balance will be taken during both patient's "off" and "on" motor states during each of the study visits. Patients will be asked to stand on a force plate (a piece of equipment that measures your balance and is located in the floor) for thirty seconds in a total of four conditions. The four sessions will be carried out as follows: (1) with eyes open while standing on firm surface, (2) with eyes closed while standing on firm surface, (3) with eyes open while standing on foam surface, and (4) with eyes closed while standing on foam surface. These sessions will be in random order and will be repeated up to 4 times.
During all the study visits, the physician will ask patients to perform some physical tests during which the Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr (H&Y) will be used to assess the severity of the patient's Parkinson's disease. Each assessment will take place during both patient's "off" and "on" motor states. Instruments that will also be used are the self-administered Freezing of Gait Questionnaire (FOGQ), to evaluate walking difficulties, and the Gait-Falls diary, to document all indoor and outdoor freezing, tripping, and falls. To assess changes in mood, patients will also complete the following instruments: the Montgomery-Asberg Depression scale (MADRS), the 15-item Geriatric Depression Scale (GDS-15) and the 20-item Zung Self-Rating Depression scale (Zung). To assess quality of life and activities of daily living, patients will complete the EQ-5D Health Questionnaire. Finally, patients will be asked to complete the Epworth Sleepiness Scale (ESS) to document any changes in sleep patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a definite diagnosis of Parkinson's disease for at least 5 years.
- •Patients with mild to severe gait disturbance.
- •Patients on a stable dose of anti-parkinsonian medications that will not be expected to require medication adjustments.
- •Mini-Mental State Examination (MMSE) score of 25 or greater.
排除标准
- •Patients with musculoskeletal disorders such as severe arthritis, post knee surgery, hip surgery, or any other condition that the investigators determine may impair assessment of gait.
- •Previous treatment with DBS (deep brain stimulation).
- •Those with history of stroke.
- •Those with cerebellar, vestibular, or sensory ataxia.
- •Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs (selegiline, rasagiline).
- •Women of childbearing potential.
研究组 & 干预措施
1. MPD
Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
干预措施: Methylphenidate (MPD) (Drug)
2. Placebo
Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
干预措施: Placebo (Drug)
结局指标
主要结局
The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.
时间窗: Week 12 and 27
Gait stride length is the distance between two consecutive steps in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.
The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.
时间窗: Week 12 and 27
Gait velocity is a measure of distance over time in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.
次要结局
- The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks(At week 12 and 27)
- Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.(Week 12 and 27)
- Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.(Week 12 and 27)
- Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.(Week 12 and 27)
- The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks(Week 12 and 27)
- The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.(Week 12 and 27)
研究者
Alberto Espay
Associate Professor
University of Cincinnati