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Completed

NCT Number: NCT04383665

Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Communication Language Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck hospital of the University of Southern California

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STN DBS 10Hz

Device

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

STN DBS 130Hz

Device

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

STN DBS off

Device

Existing DBS device turned off

Primary outcomes

  1. Delis-Kaplan Executive Function System Verbal Fluency

    Time frame: 5-15 minutes following stimulation frequency setting change.

    Number of words per category in one minute

  2. Delis-Kaplan Executive Function System Color Word Interference Task

    Time frame: 5-15 minutes following stimulation frequency setting change.

    Time to completion of a color-word interference task

  3. Random Number Generation

    Time frame: 5-15 minutes following stimulation frequency setting change.

    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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Evaluation of Neurocognitive Changes in Parkinson's Disease Patients Following Acute Low Frequency Deep Brain Stimulation

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 12, 2020
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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