Status:
COMPLETED
MER Versus MRI Guidance DBS in Parkinson's Disease
Lead Sponsor:
Baylor College of Medicine
Conditions:
Idiopathic Parkinson's Disease (PD)
Eligibility:
All Genders
30-79 years
Brief Summary
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. ...
Detailed Description
Patients who have been randomized into Group 1 will undergo DBS implantation while awake. On the morning of surgery, the patient will undergo placement of the stereotactic head frame under local anest...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01883973
Start Date
May 1 2011
End Date
December 1 2014
Last Update
November 25 2020
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030