跳至主要内容
临床试验/CTRI/2025/05/087502
CTRI/2025/05/087502招募中4 期

Tractography-based Targeting and Programming of Deep Brain Stimulation for Neurological and Psychiatric Disorders

Jaslok Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Anatomical difference between the direct and tractography-based DBS targets

研究概览

简要总结

  1. Introduction - Tractography is emerging as a precise and more personalized approach for DBS targeting and programming, especially given the evolving understanding of the physiological mechanisms underlying the therapeutic benefits of DBS. The advances in imaging and post-processing software have further influenced the interest in exploring the role of tractography. We plan to investigate the role of tractography in defining the DBS target, its correlation with the conventional targeting techniques and finally deciding if one is better than the other.

Different regions of the cortex connect differently to the target nuclei, and though there is a good amount of conformity, there is also significant variability in the areas connected. This, in turn, influences the clinical responses in the patient seen during programming. We plan to investigate the preoperative tractography-based information and use it to perform postoperative programming, especially in difficult cases of dystonia, psychiatric disorders, or Parkinson’s disease. Lastly, we intend to advocate for precision-targeting with evidence from a cohort of Indian patients.

Methodology - Patients with Parkinson’s Disease, Dystonia, Depression, Obsessive-Compulsive Disorder, and Tourette Syndrome, eligible for Deep Brain Stimulation (based on standard guidelines), will be enrolled in the study. Two investigators will independently locate direct and tractography-based targets. Attempts will be made to include both targets in the trajectory. If not, the electrode will be implanted as per the direct target. Each patient’s pacemaker will then be programmed as per clinical assessment and tracking based on one month, each with regular clinical assessments. The outcome between the two methods would be compared.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Population.
  • Patients diagnosed with Parkinson’s Disease, Dystonia, Depression, Obsessive-Compulsive Disorder, or Tourette Syndrome as per International Classification of Diseases (ICD)-10, unresponsive to the standard of care pharmacotherapy for at least 6 months. Inclusion and Exclusion Criteria.
  • The patient must be fit for general anesthesia (without or with ongoing medications).
  • The patient must meet specific diagnostic criteria for undergoing DBS: 1) as per the core Assessment Program for Surgical Interventional Therapies in Parkinson’s Disease (CAPSIT-PD) for Parkinson’s Disease and 2) Disease severity “severe” as per clinical assessment for other pathologies.

排除标准

  • Population.
  • Patients diagnosed with Parkinson’s Disease, Dystonia, Depression, Obsessive-Compulsive Disorder, or Tourette Syndrome as per International Classification of Diseases (ICD)-10, unresponsive to the standard of care pharmacotherapy for at least 6 months. Inclusion and Exclusion Criteria.
  • The patient must be fit for general anesthesia (without or with ongoing medications).
  • The patient must meet specific diagnostic criteria for undergoing DBS: 1) as per the core Assessment Program for Surgical Interventional Therapies in Parkinson’s Disease (CAPSIT-PD) for Parkinson’s Disease and 2) Disease severity “severe” as per clinical assessment for other pathologies.

结局指标

主要结局

Anatomical difference between the direct and tractography-based DBS targets

时间窗: Within 15 days of surgery

次要结局

  • Difference in the clinical efficacy of standard of care and tractography-based programming of the Implantable Pulse Generator(1 month after IPG Programming)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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