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Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forced and voluntary exercise
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Deep Brain Stimulation, DBS

Eligibility Criteria

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

Inclusion Criteria: Adult with a diagnosis of PD by a movement disorders neurologist Previous placement, at least six months, of bilateral Medtronic Precept DBS as standard of care treatment for their PD. Stable and clinically optimized DBS parameters for three months prior to enrollment. Demonstrate the ability to safely mount and dismount a recumbent exercise cycle with an upright back. Willingness to withhold antiparkinsonian medication and DBS stimulation. Exercise clearance using the American College of Sports Medicine (ACSM) Pre-participation Health Screen: a. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation; b. Those who choose not to obtain physician clearance will not be eligible for participation. Exclusion Criteria: Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent. A musculoskeletal issue that limits one's ability to cycle Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) that impacts motor or cognitive function Uncontrolled cardiovascular risk factor such as a current cardiac arrhythmia, uncontrolled hypertension, untreated deep vein thrombosis, etc.

Sites / Locations

  • Cleveland ClinicRecruiting
  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

Two modes of high intensity exercise.

Outcomes

Primary Outcome Measures

Local Field Potentials during Cognitive Testing
Change in power in frequency bands of interest
Trail Making Test A & B
Change in neuropsychological tests designed to evaluate set-switching and attention
Information Processing
Change in mobile application of simple and choice reaction time
N-Back Test
Change in working memory test of word recall
Force-tracking with n-back
Change in upper extremity motor control assessment with cognitive component

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
August 16, 2023
Sponsor
The Cleveland Clinic
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05972759
Brief Title
Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
Official Title
Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
United States Department of Defense

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
Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.
Detailed Description
Parkinson's disease (PD) is a progressive neurological disease, most prevalent in older adults, estimated to affect over 12 million people world-wide by 2040. Traditionally considered a motor disorder, the impact of PD on cognitive performance is now widely accepted with 80% of PD patients developing executive function impairments. Typical PD related cognitive effects include impaired information processing, set-switching, working memory and dual-tasking. While antiparkinsonian medication and deep brain simulation (DBS) are effective in managing disease symptoms, disease modification has remained elusive. Exercise has been proposed as the Universal Prescription for PD capable of slowing disease progression; stationary cycling in particular has been suggested as an ideal exercise modality for people with PD (PwPD). The investigator's seminal tandem cycling study was the first to utilize forced exercise (FE) in human PD patients and demonstrated a 30% improvement in clinical ratings compared to voluntary exercise (VE). Briefly, FE is a mode of high intensity exercise originating in animal models of PD in which voluntary exercise rate is augmented, but not replaced. Thus, PwPD were assisted in pedaling at a higher rate (cadence) on the tandem cycle compared to those on a standard stationary cycle performing voluntary exercise (VE). This work resulted in a paradigm shift in terms of recommending high intensity exercise for PwPD. Despite the potential of exercise to alter disease progression, its mechanism of action and effects on basal ganglia function are not understood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation, DBS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and completed a single bout of both FE and VE.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Two modes of high intensity exercise.
Intervention Type
Other
Intervention Name(s)
Forced and voluntary exercise
Intervention Description
Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.
Primary Outcome Measure Information:
Title
Local Field Potentials during Cognitive Testing
Description
Change in power in frequency bands of interest
Time Frame
an average of 3 total days
Title
Trail Making Test A & B
Description
Change in neuropsychological tests designed to evaluate set-switching and attention
Time Frame
an average of 3 total days
Title
Information Processing
Description
Change in mobile application of simple and choice reaction time
Time Frame
an average of 3 total days
Title
N-Back Test
Description
Change in working memory test of word recall
Time Frame
an average of 3 total days
Title
Force-tracking with n-back
Description
Change in upper extremity motor control assessment with cognitive component
Time Frame
an average of 3 total days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult with a diagnosis of PD by a movement disorders neurologist Previous placement, at least six months, of bilateral Medtronic Precept DBS as standard of care treatment for their PD. Stable and clinically optimized DBS parameters for three months prior to enrollment. Demonstrate the ability to safely mount and dismount a recumbent exercise cycle with an upright back. Willingness to withhold antiparkinsonian medication and DBS stimulation. Exercise clearance using the American College of Sports Medicine (ACSM) Pre-participation Health Screen: a. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation; b. Those who choose not to obtain physician clearance will not be eligible for participation. Exclusion Criteria: Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent. A musculoskeletal issue that limits one's ability to cycle Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) that impacts motor or cognitive function Uncontrolled cardiovascular risk factor such as a current cardiac arrhythmia, uncontrolled hypertension, untreated deep vein thrombosis, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MacKenzie Dunlap, BS
Phone
216-219-3949
Email
dunlapm4@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Jansen, MPH
Phone
216-445-3866
Email
aej26@case.edu
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MacKenzie Dunlap
Phone
216-219-3949
Email
dunlapm4@ccf.org
First Name & Middle Initial & Last Name & Degree
Jay Alberts, Ph.D.
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Jansen, MPH
Phone
216-445-3866
Email
jansena@ccf.org
First Name & Middle Initial & Last Name & Degree
Anson B Rosenfeldt, DPT
Phone
216-445-3277
Email
rosenfa2@ccf.org
First Name & Middle Initial & Last Name & Degree
Jay L Alberts, PhD

12. IPD Sharing Statement

Learn more about this trial

Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines

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