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Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STN DBS 10Hz
STN DBS 130Hz
STN DBS off
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Cognition, Hippocampus, Language, Memory, Neuromodulation, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keck hospital of the University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Active Comparator

Arm Label

STN DBS off

STN DBS 10Hz

STN DBS 130Hz

Arm Description

Outcomes

Primary Outcome Measures

Delis-Kaplan Executive Function System Verbal Fluency
Number of words per category in one minute
Delis-Kaplan Executive Function System Color Word Interference Task
Time to completion of a color-word interference task
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

Secondary Outcome Measures

Full Information

First Posted
May 7, 2020
Last Updated
June 24, 2021
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04383665
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Cognition, Hippocampus, Language, Memory, Neuromodulation, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STN DBS off
Arm Type
Sham Comparator
Arm Title
STN DBS 10Hz
Arm Type
Experimental
Arm Title
STN DBS 130Hz
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
STN DBS 10Hz
Intervention Description
Stimulation of existing DBS device at 100Hz, with other parameters at baseline
Intervention Type
Device
Intervention Name(s)
STN DBS 130Hz
Intervention Description
Stimulation of existing DBS device at 130Hz, with other parameters at baseline
Intervention Type
Device
Intervention Name(s)
STN DBS off
Intervention Description
Existing DBS device turned off
Primary Outcome Measure Information:
Title
Delis-Kaplan Executive Function System Verbal Fluency
Description
Number of words per category in one minute
Time Frame
5-15 minutes following stimulation frequency setting change.
Title
Delis-Kaplan Executive Function System Color Word Interference Task
Description
Time to completion of a color-word interference task
Time Frame
5-15 minutes following stimulation frequency setting change.
Title
Random Number Generation
Description
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
Time Frame
5-15 minutes following stimulation frequency setting change.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrin J Lee, MD PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck hospital of the University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Evans FJ. Monitoring attention deployment by random number generation: An index to measure subjective randomness. Bull Psychon Soc 1978;12:35-8.
Results Reference
background
PubMed Identifier
8292327
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.
Results Reference
background
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.
Results Reference
background
Links:
URL
https://www.lancaster.ac.uk/staff/towse/rgcpage.html
Description
RGCalc

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Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

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