Clinical trial NCT04383665: Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency
Official title: Evaluation of Neurocognitive Changes in Parkinson's Disease Patients Following Acute Low Frequency Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Cognition
Hippocampus
Language
Memory
Neuromodulation
Randomized controlled trial
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
2. Age \>18 years old
3. Stable medication regimen for at least 3 months.
4. Patient informed and able to give written consent
5. Able to comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

1. History of epilepsy or seizure
2. History of major substance abuse
3. Patients with baseline settings at less than 1.5 V will be excluded from the study

Primary outcomes:
measure: Delis-Kaplan Executive Function System Verbal Fluency
timeFrame: 5-15 minutes following stimulation frequency setting change.
measure: Delis-Kaplan Executive Function System Color Word Interference Task
timeFrame: 5-15 minutes following stimulation frequency setting change.
measure: Random Number Generation
timeFrame: 5-15 minutes following stimulation frequency setting change.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck hospital of the University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Darrin J Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans FJ. Monitoring attention deployment by random number generation: An index to measure subjective randomness. Bull Psychon Soc 1978;12:35-8.
citation: Spatt J, Goldenberg G. Components of random generation by normal subjects and patients with dysexecutive syndrome. Brain Cogn. 1993 Nov;23(2):231-42. doi: 10.1006/brcg.1993.1057.
citation: Towse JN, Neil D. Analyzing human random generation behavior: A review of methods used and a computer program for describing performance. Behav Res Methods Instrum Comput 1998;30:583-91.