A Case-Control Study of Psychiatric Changes after Deep Brain Stimulation of the Subthalamic Nucleus in Parkinsons Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To examine the differences in psychiatric assessment between Parkinsons disease patients undergoing STN DBS and those not undergoing this procedure
研究概览
简要总结
The impact of Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) on psychiatric symptoms in Parkinson’s Disease (PD) remains an area of uncertainty, despite notable improvements in motor symptoms reported in the literature. The existing body of research presents mixed results regarding the effect of STN-DBS on psychiatric symptoms. Furthermore, there is a paucity of studies from India specifically examining the changes in neuropsychiatric symptoms following STN DBS in PD. In light of these gaps in knowledge, the current study is strategically designed to address this void and comprehensively assess the alterations in psychiatric symptoms subsequent to Deep Brain Stimulation of the Subthalamic Nucleus in individuals diagnosed with Parkinson’s Disease. This research aims to contribute valuable insights to the understanding of the holistic impact of STN-DBS, particularly in the context of neuropsychiatric manifestations in Parkinson’s Disease.
Primary objective
• To study the psychiatric changes at 6 months after bilateral STN-DBS in patients with Parkinson’s disease
Secondary Objective
• To study the effect of DBS on quality of life in patients with Parkinson’s disease
Patients diagnosed with Parkinson’s disease, presenting at an outpatient facility in the Department of Neurology, All India Institute of Medical Science, New Delhi, will be included in the study. Patients diagnosed with Parkinson’s disease, would be selected for a Deep Brain Stimulation (DBS) procedure based on predefined inclusion/exclusion criteria. The study will include a minimum of 30 patients, calculated based on the feasibility of sampling using a convenience-based purposive sampling method. In the first group, a minimum of 20 selected patients will undergo the deep brain stimulation procedure. In the second group, a minimum of 10 controls (age and duration-matched patients with Parkinson’s disease) will be included.
Inclusion and exclusion criteria will be applied. Informed written consent will be obtained from selected participants, and the following scales will be used to assess the patient at baseline (within 1 week prior to DBS): sociodemographic and clinical variables, GMHAT, HAM-D, HAM-A, BPRS, YMRS, YBOCS, BIS, PDQ-L, UPDRS.
6 months following the completion of the DBS surgery (by the neurosurgery department), reassessment will be conducted using the instruments used in the initial assessment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients planned for DBS surgery as selected by the neurology team criteria for which is Diagnosis of idiopathic PD Patient on more than 4 years of dopamine therapy Presence of motor fluctuations and drug-related dyskinesia Age 18- 70 will be included.
- •Absence of dementia or severe cognitive impairment (HMSE score more than 23) Any gender Willing to give written informed consent Patient with good psychosocial support.
排除标准
- •Leads removed due to infection, malfunction, etc Suffering from any other severe psychiatric disorder or substance use disorder (except caffeine & nicotine) assessed through clinical interview Comorbid neurological illness (e.g., stroke, TBI, SOL) Uncontrolled medical illness (e.g., diabetes, hypertension) Severe autonomic dysfunction.
结局指标
主要结局
To examine the differences in psychiatric assessment between Parkinsons disease patients undergoing STN DBS and those not undergoing this procedure
时间窗: At baseline and at 6 months from baseline
次要结局
- To study the changes in PDQL (quality of life) post DBS(at baseline and 6 months from baseline)
研究者
Dr Shaurya Garg
All India Institute of Medical Science, New Delhi