Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency
- Conditions
- Parkinson Disease
- Interventions
- Device: STN DBS offDevice: STN DBS 130HzDevice: STN DBS 10Hz
- Registration Number
- NCT04383665
- Lead Sponsor
- University of Southern California
- Brief Summary
Rationale: Parkinson's disease patients with deep brain stimulation electrodes represent a unique opportunity to study the influence of basal ganglia on neurocognitive function.
Intervention: Patients' deep brain stimulators will be turned off or on and the frequency will be changed to either theta or gamma.
Objectives: To identify differences in higher cognitive functions with stimulation "on" and "off" and theta versus gamma frequency stimulation.
Study population: 12 patients who had previously undergone bilateral STN deep brain stimulation implantation.
Study methodology: Patients will undergo four sessions of neuropsychological testing (RNGT, verbal fluency, D-KEFS CWIT) at baseline, no stimulation, theta stimulation and gamma stimulation, in random order over one day.
Study outcomes: Test results of RNGT, verbal fluency, D-KEFS CWIT. Follow-up: none
Statistics: Test results will be analyzed using within-subjects statistical tests.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
- Age >18 years old
- Stable medication regimen for at least 3 months.
- Patient informed and able to give written consent
- Able to comply with all testing, follow-ups and study appointments and protocols
- History of epilepsy or seizure
- History of major substance abuse
- Patients with baseline settings at less than 1.5 V will be excluded from the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description STN DBS off STN DBS off - STN DBS 130Hz STN DBS 130Hz - STN DBS 10Hz STN DBS 10Hz -
- Primary Outcome Measures
Name Time Method Delis-Kaplan Executive Function System Verbal Fluency 5-15 minutes following stimulation frequency setting change. Number of words per category in one minute
Delis-Kaplan Executive Function System Color Word Interference Task 5-15 minutes following stimulation frequency setting change. Time to completion of a color-word interference task
Random Number Generation 5-15 minutes following stimulation frequency setting change. Listing of 100 numbers at 1 Hz in a random order.
Evan's RNG: a measure of disproportion with which one number follows another in a sequence. Scores range from 0 (equal proportion of sequence pairs) to 1 (maximum disproportion of sequence pairs). A higher score indicates a lower randomness and poorer exective function.
Count score 1: a measure of propensity to count in steps of 1. The length of each sequence with steps of 1 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 1) to 100000 (all sequences with steps of 1). A higher score indicates lower randomness and poorer exective function.
Count score 2: a measure of propensity to count in steps of 2. The length of each sequence with steps of 2 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 2) to 100000 (all sequences with steps of 2). A higher score indicates lower randomness and poorer exective function.
Evan's RNG, count score 1 and cou
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Keck hospital of the University of Southern California
🇺🇸Los Angeles, California, United States