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

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized DBS adjustments
Sponsored by
Darlene Floden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Personalized DBS adjustments

Arm Description

Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Outcomes

Primary Outcome Measures

Reaction time
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'
Verbal Fluency
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Finger tapping speed
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'

Secondary Outcome Measures

Full Information

First Posted
May 23, 2018
Last Updated
August 23, 2023
Sponsor
Darlene Floden
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1. Study Identification

Unique Protocol Identification Number
NCT03800108
Brief Title
Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
Acronym
FREQUENCY
Official Title
Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Darlene Floden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized DBS adjustments
Arm Type
Other
Arm Description
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Intervention Type
Procedure
Intervention Name(s)
Personalized DBS adjustments
Intervention Description
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Primary Outcome Measure Information:
Title
Reaction time
Description
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'
Time Frame
30-60 minutes after stimulation adjustment
Title
Verbal Fluency
Description
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Time Frame
30-60 minutes after stimulation adjustment
Title
Finger tapping speed
Description
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
Time Frame
30-60 minutes after stimulation adjustment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 40 and 70 years of age, Ability to provide informed consent, Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist, Disease duration of at least 4 years, Treated with bilateral STN DBS for at least 3 months prior to study enrollment. Exclusion Criteria: History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy) History of other central nervous system disease (excluding migraine), 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), Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation, Current alcohol or substance abuse, Lack of fluency in English which would invalidate cognitive testing, Hearing or visual impairment precluding cognitive testing. Exclusion criteria for Day 2 procedures: Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darlene Floden, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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