Parkinson DiseaseNCT05905302
The Impact of Exercise on Subthalamic Nucleus Neural Activity in Parkinson's Disease
A study testing Forced and Voluntary Exercise in people with Parkinson Disease and Deep Brain Stimulation, run by Jay Alberts at 1 site in United States.
Trial summary
Fifteen PwPD who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while Off antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre-, during FE or VE and post-exercise). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation
- What is being tested?
- Forced and Voluntary Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Fifteen PwPD who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while Off antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre-, during FE or VE and post-exercise). The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III Motor Exam and upper extremity force-tracking task will be used to determine motor response to exercise.
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. 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).Our seminal tandem cycling study was the first to utilize forced exercise (FE) in human PD patients and demonstrate 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. Currently, we are involved in two multi-site clinical trials aimed at identifying the potential of high intensity exercise to slow PD (2R01NS073717 \& 1U01NS113851). Despite the potential of exercise to alter disease progression, its mechanism of action and effects on basal ganglia function are not understood. The loss of dopamine producing neurons associated with PD results in hypersynchrony of basal ganglia motor circuits that underlies PD symptoms. Recent animal studies using FE evaluated neural activity, local field potentials (LFPs), from the primary motor cortex (M1) to estimate the impact of exercise on basal ganglia function. Following FE, neural hypersynchrony in the beta (13-35Hz) frequency band was reduced in M1, which was proposed to underlie improved motor function. M1 activity is impacted by the activity in the subthalamic nucleus (STN), a structure in the basal ganglia, via the direct and indirect pathways. The impact of high intensity exercise, VE or FE, on STN hypersynchrony in humans is unknown. Recording of STN neural activity, until recently, was only possible during DBS surgery or in patients whose electrode was temporarily externalized immediately post-surgery. Neither approach is feasible or safe to systematically evaluate the effects of exercise on basal ganglia function. Recently, the Medtronic Percept DBS platform received FDA approval. The Percept platform records and streams neural activity from the DBS electrode within the STN. This project, for the first time, will record neural activity from the STN during two modes of high intensity exercise, FE and VE, in PwPD to identify the potential mechanism underlying the beneficial effects of exercise on PD. Our underlying hypothesis is that high intensity exercise reduces STN hypersynchrony which facilitates cortico-basal ganglia-thalamocortical circuit functionality thereby improving motor function following exercise.
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Being tested
- Forced and Voluntary Exercise
- 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
Participants will complete a forced exercise (FE) and voluntary exercise (VE) session. Forced exercise is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. Voluntary exercise is standard stationary cycling. FE and VE exercise sessions will be Off antiparkinsonian medication. The order in which exercise session is conducted first will be randomized. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre, during FE or VE and post-exercise).
| 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.
Finger Tapping
Finger tapping portion of the the Movement Disorders Society-Unified Parkinson's Disease Rating Scale subscale III (MDS-UPDRS III). The MDS-UPDRS III assesses motor function in Parkinson's disease using eighteen items scored on a 0-4 scale resulting in a score ranging from 0-72. A higher score (larger number) indicates more motor symptoms. For this outcome, item number 4 (finger tapping rated 0-4) for the participant's dominant hand in the MDS-UPDRS III was analyzed.
Measured: Pre- and Post-Exercise
Force Tracking
Participants were required to modulate the precision grip force of their dominant hand to match a target trajectory on a computer screen. Time within range is the percentage of the trial that participants were within 5% of the target force, with higher values indicating improved accuracy.
Measured: Pre- and Post-Exercise
Local Field Potential
Normalized beta band activity (the change in beta power relative to a resting baseline) is reported as the mean across voluntary exercise (VE) and forced exercise (FE) sessions. The ON DBS condition was not tested for this outcome measure.
Measured: Pre- and Post-Exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Aug 2023
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Fifteen Parkinson's disease patients who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while OFF antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jay Alberts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jay Alberts, The Cleveland Clinic
- Investigators
- Jay Alberts, PhD, Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905302
- Sponsor's protocol ID
- 1R21NS129147-01
- Status last verified
- Jul 2025
- First submitted
- 19 May 2023
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data is being shared.
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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise on Subthalamic Nucleus Neural Activity in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05905302
- Acronym / sponsor ID
- 1R21NS129147-01
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jay AlbertsUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fifteen PwPD who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while Off antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre-, during FE or VE and post-exercise). The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III Motor Exam and upper extremity force-tracking task will be used to determine motor response to exercise.
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. 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).Our seminal tandem cycling study was the first to utilize forced exercise (FE) in human PD patients and demonstrate 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. Currently, we are involved in two multi-site clinical trials aimed at identifying the potential of high intensity exercise to slow PD (2R01NS073717 \& 1U01NS113851). Despite the potential of exercise to alter disease progression, its mechanism of action and effects on basal ganglia function are not understood. The loss of dopamine producing neurons associated with PD results in hypersynchrony of basal ganglia motor circuits that underlies PD symptoms. Recent animal studies using FE evaluated neural activity, local field potentials (LFPs), from the primary motor cortex (M1) to estimate the impact of exercise on basal ganglia function. Following FE, neural hypersynchrony in the beta (13-35Hz) frequency band was reduced in M1, which was proposed to underlie improved motor function. M1 activity is impacted by the activity in the subthalamic nucleus (STN), a structure in the basal ganglia, via the direct and indirect pathways. The impact of high intensity exercise, VE or FE, on STN hypersynchrony in humans is unknown. Recording of STN neural activity, until recently, was only possible during DBS surgery or in patients whose electrode was temporarily externalized immediately post-surgery. Neither approach is feasible or safe to systematically evaluate the effects of exercise on basal ganglia function. Recently, the Medtronic Percept DBS platform received FDA approval. The Percept platform records and streams neural activity from the DBS electrode within the STN. This project, for the first time, will record neural activity from the STN during two modes of high intensity exercise, FE and VE, in PwPD to identify the potential mechanism underlying the beneficial effects of exercise on PD. Our underlying hypothesis is that high intensity exercise reduces STN hypersynchrony which facilitates cortico-basal ganglia-thalamocortical circuit functionality thereby improving motor function following exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fifteen Parkinson's disease patients who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while OFF antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded.
| 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 ExerciseParticipants will complete a forced exercise (FE) and voluntary exercise (VE) session. Forced exercise is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. Voluntary exercise is standard stationary cycling. FE and VE exercise sessions will be Off antiparkinsonian medication. The order in which exercise session is conducted first will be randomized. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre, during FE or VE and post-exercise). | Other | Experimental Arm |
Primary outcome
Finger Tapping
Time frame: Pre- and Post-Exercise
Finger tapping portion of the the Movement Disorders Society-Unified Parkinson's Disease Rating Scale subscale III (MDS-UPDRS III). The MDS-UPDRS III assesses motor function in Parkinson's disease using eighteen items scored on a 0-4 scale resulting in a score ranging from 0-72. A higher score (larger number) indicates more motor symptoms. For this outcome, item number 4 (finger tapping rated 0-4) for the participant's dominant hand in the MDS-UPDRS III was analyzed.
Force Tracking
Time frame: Pre- and Post-Exercise
Participants were required to modulate the precision grip force of their dominant hand to match a target trajectory on a computer screen. Time within range is the percentage of the trial that participants were within 5% of the target force, with higher values indicating improved accuracy.
Local Field Potential
Time frame: Pre- and Post-Exercise
Normalized beta band activity (the change in beta power relative to a resting baseline) is reported as the mean across voluntary exercise (VE) and forced exercise (FE) sessions. The ON DBS condition was not tested for this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No. No individual participant data is being shared.
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Parkinson Disease
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, PhD 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 and Deep Brain Stimulation, run by Jay Alberts 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 23 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Finger Tapping (time frame: Pre- and Post-Exercise). The study lists 3 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 NCT05905302, 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 23 Dec 2025.