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临床试验/CTRI/2024/09/074491
CTRI/2024/09/074491尚未招募不适用

Perioperative changes in regional cerebral oxygenation cerebral blood flow velocity and pulmonary function tests in patients undergoing deep brain stimulation A Prospective Observational study

NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES NIMHANS BENGALURU1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
• The comparison of rSO2 (regionalcerebral oxygenation) changes during the DBS electrode placement, stimulation and after activation.

研究概览

简要总结

Deep brain stimulation (DBS) is the functional surgery performed for Parkinson’s disease, dystonia, essential tremors, epilepsy, chronic pain, and psychiatric diseases (obsessive-compulsive disorder, refractory major depression). DBS is nondestructive, reversible, and adjustable surgical therapy performed based on the disease characteristic, treatment availability, and patient preferences .  DBS electrodes are placed bilaterally for Parkinson’s disease and unilaterally for essential tremors. DBS is known to improve the quality of life and reduce drug requirements. In Parkinson’s disease, the degeneration of the substantia nigra and the corresponding loss of dopamine production results in excessive GPi activity inhibiting the thalamus and reducing the thalamocortical activity resulting in akinesia and rigidity. High-frequency DBS suppresses the neuronal activity of GPi and activates the efferent fibre pathway.

In DBS surgery, the correct placement of electrodes is guided by stereotactic frame-based imaging. Additional methods include localization (microelectrode recording MER and macrostimulation). Initially, the stimulation electrodes are placed, and electrical stimulation is passed to record the improvement in the motor activity in the patient to determine the most optimal electrode location. Side effects are also monitored at different stimulation strengths. After the location is determined, the stimulation electrodes are replaced with the permanent electrodes, which are activated after 1-2 weeks. Currently, preoperative levodopa responsiveness is the only predictor of postsurgical improvement after DBS. Neural activation induces an increase in regional cerebral blood flow (rCBF) and metabolism. Since the increase in regional cerebral blood flow exceeds the increase in tissue oxygen demands of activated brain tissue, the blood concentration of deoxy-Hb decreases while those of oxy-Hb and total-Hb increase.

Problem statement: There are many physiological changes described before and after activation of Insitu DBS electrodes - an increase in blood flow and changes in cerebral oxygenation corresponding with the improvement in motor activity. The changes during the placement and neurological testing are not studied due to limitations of surgical access, equipment and the confounding influence of anaesthetic agents. In this study, we will perform continuous regional cerebral oxygenation changes in the prefrontal area throughout the neurological testing and electrode placement. The observed changes and their impact on the postsurgical outcomes will be evaluated.

Hypothesis: We hypothesize that there will be improvement in the rSO2 values as early as during the neurological testing stimulation. The extent of the increase in rSO2 should correlate with the improvement in motor activity. This improvement in motor activity should also improve their pulmonary functions - either by improving muscle rigidity or improved coordination, resulting in a better test performance. There might be an improvement in cerebral blood flow velocities after DBS.

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

  • All patients between 18-70 years of age undergoing DBS surgery.

排除标准

  • Known respiratory pathology
  • ICSOL or head injury in the past
  • Known cardiac failure
  • Refusal of consent.

结局指标

主要结局

• The comparison of rSO2 (regionalcerebral oxygenation) changes during the DBS electrode placement, stimulation and after activation.

时间窗: • rSO2 (regional cerebral oxygenation) values at baseline, intraoperatively during the DBS electrode placement & stimulation, 24 hours before and 24 hours after activation of battery

次要结局

  • • To compare the changes in middle cerebral artery velocity before electrode insertion & after insertion & activation of the electrode.(• To compare the change in rSO2 to the change in the MDS-UPDRS scale after DBS.)

研究者

发起方
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES NIMHANS BENGALURU
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

NITESH KUMAR

NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES(NIMHANS) BENGALURU

研究点 (1)

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