NCT05972759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

July 11, 2023

Last Update Submit

February 24, 2026

Conditions

Parkinson Disease

Keywords

Deep Brain StimulationDBS

Outcome Measures

Primary Outcomes (5)

  • Local Field Potentials during Cognitive Testing

    Change in power in frequency bands of interest

    an average of 3 total days

  • Trail Making Test A & B

    Change in neuropsychological tests designed to evaluate set-switching and attention

    an average of 3 total days

  • Information Processing

    Change in mobile application of simple and choice reaction time

    an average of 3 total days

  • N-Back Test

    Change in working memory test of word recall

    an average of 3 total days

  • Force-tracking with n-back

    Change in upper extremity motor control assessment with cognitive component

    an average of 3 total days

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Two modes of high intensity exercise.

Other: Forced and voluntary exercise

Interventions

Forced and voluntary exerciseOTHER

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.

Experimental Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Koop MM, Rosenfeldt AB, Berki V, Bazyk A, Davidson S, Malan NS, Nagel S, Walter BL, Liao JY, Alberts JL. A novel methodological approach to understanding the cortical and subcortical effects of aerobic exercise in Parkinson's disease. Front Hum Neurosci. 2025 Oct 20;19:1657049. doi: 10.3389/fnhum.2025.1657049. eCollection 2025.

    PMID: 41189627DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jay Alberts, Ph.D.

    Staff

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2023

First Posted

August 2, 2023

Study Start

August 15, 2023

Primary Completion

February 12, 2026

Study Completion

February 12, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(1)