Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS (FREQUENCY)

February 3, 2025 updated by: Darlene Floden
This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Between 40 and 70 years of age,
  2. Ability to provide informed consent,
  3. Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
  4. Disease duration of at least 4 years,
  5. Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Exclusion Criteria:

  1. History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
  2. History of other central nervous system disease (excluding migraine),
  3. Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
  4. Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
  5. Current alcohol or substance abuse,
  6. Lack of fluency in English which would invalidate cognitive testing,

  7. Hearing or visual impairment precluding cognitive testing.

    Exclusion criteria for Day 2 procedures:

  8. Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Personalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Procedure: Personalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Fluency
Time Frame: 30-60 minutes after stimulation adjustment
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
30-60 minutes after stimulation adjustment
Reaction Time
Time Frame: 30-60 minutes after stimulation adjustment
Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
30-60 minutes after stimulation adjustment
Finger Tapping Speed
Time Frame: 30-60 minutes after stimulation adjustment
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
30-60 minutes after stimulation adjustment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Darlene Floden

Investigators

  • Principal Investigator: Darlene Floden, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Actual)

January 14, 2020

Study Completion (Actual)

January 14, 2020

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-1350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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