Status:
COMPLETED
Combined Theta-gamma STN Stimulation for Verbal Fluency in Parkinson Disease
Lead Sponsor:
University of Turin, Italy
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) is an established, effective, and relatively safe therapeutic option for Parkinson's disease (PD) patients presenting levodopa-related mot...
Detailed Description
Each patient will receive two treatment periods, each lasting one month, in a randomized, cross-over, double-blind study design. Patients will be randomly assigned to one of two sequences: Group 1 wi...
Eligibility Criteria
Inclusion
- Age \>18 years old,
- Optimized DBS therapy in the last month,
- Stable medication regimen in the last month
- Able to provide informed consent
- Fluent in Italian
- Able to complete cognitive testing
- Patients implanted with bilateral Vercise Cartesia™ Directional Leads in the STN connected to a Vercise™ or Vercise Gevia™ or Vercise Genus™ DBS system
Exclusion
- History of dementia (MMSE ≤ 25),
- Major substance abuse,
- Stimulation provided in the more ventral contact
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06509048
Start Date
November 10 2023
End Date
September 30 2024
Last Update
December 6 2024
Active Locations (1)
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1
AOU Città della Salute e della Scienza Torino
Torino, Italy