Effect of Transcranial Magnetic Stimualtion on changes in Microel-Electrode Recording patternspatient with Parkinsons Disease undergoing Deep Brain Stimulation: A Randomized Sham Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- UPDRS, PDQ 39, LED,
研究概览
简要总结
rTMS is known to have neuromodulatory effects in Parkinson’s Disease but the mechanisms by which the motor benefits are incurred largely remain obscure. The objective of this study is to understand the cortico-subcortical plasticity with resting fMRI and Microelectrode Recording (MER) in patients with Parkinson’s Disease (PWP). This study thus involves modulating the motor cortical areas and observe the clinical and imaging outcome and attempt to correlate with subcortical MER pattern. The subcortical MER patterns would provide a measure of status of subcortical modulation by cortical rTMS. This may provide an insight into mechanisms of rTMS palsticity. The PWP will be divided into 2 groups and clinical, motor and imaging outcomes shall be observed before and after rTMS protocol. Both the group subjects would then undergo routine Deep Brain Stimualtion surgery during which the MER will be recorded. MER will be assessed between groups with real and sham rTMS. Any changes in the MER patterns will be correlated with the changes in clinical and resting state fMRI; thus providing insight into the possible mechanisms of action rTMS in producing motor benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of clinically definite PD, defined by UKPD brain bank clinical and diagnostic criteria.
- •With presence of at least 1 out of 3 cardinal motor features of PD (resting tremor, rigidity, and postural impairment like bradykinesia);
- •PD patients of both gender with H&Y stage above 1 to
- •PD patients between age 45 to 75 on stable medication for at least 30 days.
排除标准
- •Features suggestive of other causes of Parkinsonism/ Parkinson-plus syndromes;
- •History of ICSOL (intracranial space occupying lesion) or brain surgeries, significant headaches, epilepsy or seizure disorder, mass lesions, or major head trauma leading to loss of consciousness of any length;
- •Family (1st degree relatives) history of epilepsy;
- •Presence of contraindications for functional magnetic resonance imaging (fMRI) like metal implants, and claustrophobia;
- •History of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year;
- •Need for rapid clinical response due to conditions such as psychosis, or suicide tendency;
- •Patients with uncontrolled hypertension and diabetes and other uncontrolled medical illness.
- •Patients with hypertension or diabetes would be included only if they are stable on medication for last six months.
结局指标
主要结局
UPDRS, PDQ 39, LED,
时间窗: Day 1 and Day 6
次要结局
- resting fMRI(Day 1 and Day 6)
- MER(During Scheduled DBS surgery)