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Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

NCT04383665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-15

Study results available
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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

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

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Darrin J Lee, MD PhD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-03-03
Completion
2020-03-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383665 on ClinicalTrials.gov