Parkinson DiseaseNCT05972759
Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
A study testing Forced and voluntary exercise in people with Parkinson Disease, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Forced and voluntary exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Forced and voluntary exercise
- Keywords
- Deep Brain Stimulation, DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Two modes of high intensity exercise. Receives: Other: Forced and voluntary exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Field Potentials during Cognitive Testing
Change in power in frequency bands of interest
Measured: an average of 3 total days
Trail Making Test A & B
Change in neuropsychological tests designed to evaluate set-switching and attention
Measured: an average of 3 total days
Information Processing
Change in mobile application of simple and choice reaction time
Measured: an average of 3 total days
N-Back Test
Change in working memory test of word recall
Measured: an average of 3 total days
Force-tracking with n-back
Change in upper extremity motor control assessment with cognitive component
Measured: an average of 3 total days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start15 Aug 2023
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Jay Alberts, The Cleveland Clinic
- Investigators
- Jay Alberts, Ph.D., Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972759
- Sponsor's protocol ID
- 22-568
- Other IDs
- CDMRP-PD220020
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41189627
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
- ClinicalTrials.gov ID
- NCT05972759
- Acronym / sponsor ID
- 22-568
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, DBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: Forced and voluntary exerciseTwo modes of high intensity exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced and voluntary exerciseTwenty-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. | Other | Experimental Arm |
Primary outcome
Local Field Potentials during Cognitive Testing
Time frame: an average of 3 total days
Change in power in frequency bands of interest
Trail Making Test A & B
Time frame: an average of 3 total days
Change in neuropsychological tests designed to evaluate set-switching and attention
Information Processing
Time frame: an average of 3 total days
Change in mobile application of simple and choice reaction time
N-Back Test
Time frame: an average of 3 total days
Change in working memory test of word recall
Force-tracking with n-back
Time frame: an average of 3 total days
Change in upper extremity motor control assessment with cognitive component
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Derived from this study: PubMed 41189627Koop 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Alberts, Ph.D. principal investigator
Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced and voluntary exercise in people with Parkinson Disease, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Field Potentials during Cognitive Testing (time frame: an average of 3 total days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.