NCT04383665

Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

Evaluation of Neurocognitive Changes in Parkinson's Disease Patients Following Acute Low Frequency Deep Brain Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	STN DBS 10Hz	Stimulation of existing DBS device at 100Hz, with other parameters at baseline
DEVICE	STN DBS 130Hz	Stimulation of existing DBS device at 130Hz, with other parameters at baseline
DEVICE	STN DBS off	Existing DBS device turned off

Timeline

• Start date: 2020-01-31
• Primary completion: 2020-03-03
• Completion: 2020-03-03
• First posted: 2020-05-12
• Last updated: 2021-07-15
• Results posted: 2021-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study