Status:
TERMINATED
Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
Lead Sponsor:
Darlene Floden
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).
Detailed Description
Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS setting...
Eligibility Criteria
Inclusion
- Between 40 and 70 years of age,
- Ability to provide informed consent,
- Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
- Disease duration of at least 4 years,
- Treated with bilateral STN DBS for at least 3 months prior to study enrollment.
Exclusion
- History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
- History of other central nervous system disease (excluding migraine),
- Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
- Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
- Current alcohol or substance abuse,
- Lack of fluency in English which would invalidate cognitive testing,
- Hearing or visual impairment precluding cognitive testing.
- Exclusion criteria for Day 2 procedures:
- Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)
Key Trial Info
Start Date :
May 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03800108
Start Date
May 30 2018
End Date
January 14 2020
Last Update
February 5 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195