MER Versus MRI Guidance DBS in Parkinson's Disease
Completed
Conditions studied: Idiopathic Parkinson's Disease (PD)
In brief
Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain stimulation surgery in the awake patient using microelectrode recording to guide final electrode placement. Microelectrode recording is a means of analyzing the electrical activity of the brain, and assessing whether we have found the target for the deep brain stimulator electrode. However, no evidence exists that microelectrode recording improves patient outcomes. The use of microelectrode recording does extend the duration of surgery and there is evidence to suggest that microelectrode recording may increase the risk of bleeding in the brain during surgery.
Key facts
- Study ID
- NCT01883973
- Run by
- Baylor College of Medicine
- People needed
- 7
- Starts
- 2011-05-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2020-11-25
Who can join
Age: 30 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Determined to be candidates for subthalamic nucleus (STN) or Globus pallidus (GPi) DBS by consensus recommendation of a multidisciplinary team as evidenced by:
- Ability to provide informed consent as determined by preoperative neuropsychological assessment
- Optimized medically by a neurologist who is an expert in the treatment of movement disorders.
- Persistent motor symptoms which are not effectively controlled with optimal medical management. These symptoms may include levodopa-induced dyskinesias, tremor, or fluctuations in the effectiveness of levodopa throughout the day.
You may not qualify if…
- Dementia
- Previous intracranial surgery
- Intracranial tumor
- Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
- Medical co-morbidities that would make the patient a poor surgical candidate
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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