N/A
N=12
Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04383665 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Delis-Kaplan Executive Function System Verbal Fluency — 12.75; 13.25; 13.58; 13.83 Words per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STN DBS 10Hz (Device); STN DBS 130Hz (Device); STN DBS off (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delis-Kaplan Executive Function System Verbal Fluency |
12.75; 13.25; 13.58; 13.83; 11.33; 11.83 | — |
| PRIMARY Delis-Kaplan Executive Function System Color Word Interference Task |
33.83; 35.00; 34.33; 24.58; 24.75; 24.17 | — |
| PRIMARY Random Number Generation |
0.35; 0.35; 0.37; -3.10; -3.21; -2.90 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04383665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.