A Sensorimotor Contingency-based Musical Walking Program for People Living With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in brain imaging signals (fMRI)
研究概览
简要总结
This study will investigate the effects of a contingency-based musical walking intervention program called Ambulosono on neural mechanisms in the brain. The investigators will investigate the long-term impact of Ambulosono on brain plasticity with functional MRI technique. Participants will undergo 3 months of Ambulosono training and their pre-training and post-training fMRI brain scans will be compared to understand the neural networks and brain mechanisms following this intervention. The investigators hypothesized that Ambulosono may induce functional compensatory reorganization of neural networks in the brain. This project will allow us to address the important potential confound of placebo influence and to aid in optimizing this intervention program. Additionally, the investigators are hoping to investigate the synergistic effects of rasagiline and exercise; the investigators' hypothesis is that there will be a positive synergistic effect, and that exercise will augment the effectiveness of rasagiline in treating Parkinson's symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 19 years of age
- •Confirmed diagnosis of Parkinson's Disease
- •Can walk 5 to 10 minutes unassisted
- •Have a safe place to walk (outdoor or indoor)
- •Have mild to moderate Parkinson's disease (HY1-3)
- •Be able to lay flat in the scanner for the period of the study
- •No reliance on wheelchair or other walking aid for ambulation
- •Absence of any other serious medical conditions such as hearing impairment and dementia
- •No history of other neurological and psychiatric illnesses
- •No recent musculoskeletal impairment or injuries that may prevent walking
排除标准
- •Under 19 years of age
- •Unconfirmed PD diagnosis
- •Require walking aid, wheelchair-bound
- •No access to safe walking pathway
- •Severe PD (Hoehn & Yahr stages>3)
- •Impaired hearing
- •Atypical Parkinsonism
- •Concurrent dementia
- •Recent knee, hip or foot injury (need permission from doctor)
- •Exclusion Criteria for fMRI
- •Pacemaker
- •Brain aneurysm clip
- •Cochlear implant
- •Recent surgery within the past 6 weeks
- •Possibility of pregnancy
- •Electrical stimulator for nerves or bones
- •Implanted infusion pump
- •History of any eye injury involving metal fragments
- •History of working with metals (grinding, machining, or welding)
- •Artificial heart valve
- •Orthopaedic hardware (artificial joint, plate, screws, rods)
- •Other metallic prostheses
- •Coil, catheter or filter in any blood vessel
- •Ear or eye implant
- •Recent tattoos within the past 6 weeks
- •Shrapnel, bullets, or other metallic fragments
- •Medication releasing skin patches (nicotine, birth control, nitroglycerine)
研究组 & 干预措施
MCW
Music Contingent Walking (MCW) group: study-specific musical device that measures gait and plays music in a portable manner as the participant is walking is set at a threshold individually calculated per participant, and the music will stop playing when walking strides fall below this threshold.
干预措施: Exercise (Behavioral)
MCW
Music Contingent Walking (MCW) group: study-specific musical device that measures gait and plays music in a portable manner as the participant is walking is set at a threshold individually calculated per participant, and the music will stop playing when walking strides fall below this threshold.
干预措施: Music (Other)
NCMW
Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.
干预措施: Exercise (Behavioral)
NCMW
Non-contingent Music Walking (NCMW) group: music on all the time regardless of the stride size.
干预措施: Music (Other)
NMW
Non-music walking (NMW/silent) group: no music on at all regardless of step size.
干预措施: Exercise (Behavioral)
MCW+rasagiline
Music contingent walking with rasagiline group: same paradigm as the previous MCW, but with rasagiline prescribed as adjunct therapy.
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day
干预措施: Azilect (Drug)
MCW+rasagiline
Music contingent walking with rasagiline group: same paradigm as the previous MCW, but with rasagiline prescribed as adjunct therapy.
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day
干预措施: Exercise (Behavioral)
MCW+rasagiline
Music contingent walking with rasagiline group: same paradigm as the previous MCW, but with rasagiline prescribed as adjunct therapy.
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day
干预措施: Music (Other)
MMW+rasagiline
Non-music (silent) walking with rasagiline group: same paradigm as the previous NMW, but with rasagiline prescribed as adjunct therapy.
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day
干预措施: Azilect (Drug)
MMW+rasagiline
Non-music (silent) walking with rasagiline group: same paradigm as the previous NMW, but with rasagiline prescribed as adjunct therapy.
Dosage: 0.5 mg/day for the first 2 weeks to be subsequently increased to 1 mg/day
干预措施: Exercise (Behavioral)
结局指标
主要结局
Change from baseline in brain imaging signals (fMRI)
时间窗: one month and four months
resting state data task-evoked data cortical thickness volume sizes of specified brain structures
次要结局
- Change from baseline in motor symptoms of PD(baseline and one month and four months)
- Change from baseline in cognition of PD(baseline and one month and four months)