Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

NCT04383665 | Completed Results FDA Device

• 1 other identifier: HS-19-00518
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Cognition; Hippocampus; Language; Memory; Neuromodulation; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Delis-Kaplan Executive Function System Verbal Fluency

  Number of words per category in one minute

  5-15 minutes following stimulation frequency setting change.

• Delis-Kaplan Executive Function System Color Word Interference Task

  Time to completion of a color-word interference task

  5-15 minutes following stimulation frequency setting change.

• Random Number Generation

  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

  5-15 minutes following stimulation frequency setting change.

Study Arms (3)

STN DBS off

SHAM COMPARATOR

Device: STN DBS off

STN DBS 10Hz

EXPERIMENTAL

Device: STN DBS 10Hz

STN DBS 130Hz

ACTIVE COMPARATOR

Device: STN DBS 130Hz

Interventions

STN DBS 10Hz DEVICE

Stimulation of existing DBS device at 100Hz, with other parameters at baseline

STN DBS 10Hz

STN DBS 130Hz DEVICE

Stimulation of existing DBS device at 130Hz, with other parameters at baseline

STN DBS 130Hz

STN DBS off DEVICE

Existing DBS device turned off

STN DBS off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck hospital of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (3)

• Evans FJ. Monitoring attention deployment by random number generation: An index to measure subjective randomness. Bull Psychon Soc 1978;12:35-8.

  BACKGROUND

• 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.

  PMID: 8292327 BACKGROUND

• 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.

  BACKGROUND

Related Links

• RGCalc

MeSH Terms

Conditions

Parkinson Disease; Language

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Communication; Behavior

Limitations and Caveats

Our study did not control for motor state during testing. Our sample population was not fully representative of the worldwide population of patients with PD. Our study was not designed nor powered to investigate inter-subject differences such as age, time from DBS implantation, education, first language, or motor function. Unknown is the adequacy of a 5-min period of stimulation prior to each round of neuropsychological testing.

Results Point of Contact

• Title: Dr Darrin Lee
• Organization: Keck School of Medicine of University of Southern California

darrinjl@usc.edu

(323) 442-5720

Study Officials

• Darrin J Lee, MD PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: January 31, 2020
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)