Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of enrolled subjects that remain in study
研究概览
简要总结
This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective, randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study will look at BDNF-TrkB signaling and cortical plasticity.
详细描述
Twenty-four PD patients (n=24) will be randomly assigned to receive one of two interventions for a duration of two weeks. In Group 1, subjects will participate in daily sessions of sham-rTMS followed by supervised aerobic exercise (Sham rTMS+Aerobic); in Group 2, subjects will participate in a combination of rTMS and supervised aerobic exercise (Real rTMS+Aerobic). Serum BDNF-TrkB signaling in lymphocytes and TMS-based electrophysiological measures of LTP-like plasticity will be measured. A comparison of such measures in a group of patients with PD and in a group of age-matched controls (n=12) will be analyzed to establish the effect of the disease on indices of plasticity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Diagnosis of PD according to the UK Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders;
- •Hoehn and Yahr stage II to III;
- •On a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3-6 months.
- •Inclusion Criteria (Healthy Controls)
- •Male or Female; aged 35-85
- •Exclusion Criteria (Healthy Controls)
- •History of seizure disorder, including febrile seizures;
- •Neurological disorder including PD, stroke, traumatic brain injury, fainting spells or syncope of unknown cause(s);
- •Major or unstable medical illness;
- •Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
- •Untreated depression, or score of >20 on Beck Depression Inventory II;
- •Taking any of the following medications within the six weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, theophylline, calcium channel blockers, beta blockers, tadalafil, vardenafil, avanafil, and sildenafil;
- •Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) <20;
- •Any clinically significant abnormality on vital signs
- •Cardiopulmonary limitations: untreated high blood pressure, history of heart insufficiency (class II-III), coronary vascular disease, angina, arrhythmia, dyspnea on exertion and asthma
排除标准
- 未提供
研究组 & 干预措施
Group 1: Sham Group
Sham group will receive Sham rTMS+Aerobic Exercise
干预措施: Sham rTMS (Behavioral)
Group 1: Sham Group
Sham group will receive Sham rTMS+Aerobic Exercise
干预措施: Supervised aerobic exercise (Behavioral)
Group 2: Real Group
rTMS+Aerobic Exercise
干预措施: Real rTMS (Other)
Group 2: Real Group
rTMS+Aerobic Exercise
干预措施: Supervised aerobic exercise (Behavioral)
结局指标
主要结局
Number of enrolled subjects that remain in study
时间窗: 2 Weeks
Recruitment Enrollment Numbers
时间窗: 2 Weeks
次要结局
- Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)(2 Weeks)
- Freezing of Gait Questionnaire (FOG-Q)(2 Weeks)
- Parkinson's Disease Sleep Scale (PDSS)(2 Weeks)
- Parkinson's Disease Quality of Life (PDQ-39)(2 Weeks)
- Frontal Function Assessment (FAB)(2 Weeks)
- LASA Physical Activity Questionnaire (LAPAQ)(2 Weeks)
- Measurements of lymphocytes(2 Weeks)
- Measurements of TrkB(2 Weeks)
- Measurements of serum BDNF(2 Weeks)
- Timed Up and Go Test(2 Weeks)