Trial Outcomes & Findings for The Impact of Exercise on Subthalamic Nucleus Neural Activity in Parkinson's Disease (NCT NCT05905302)
NCT ID: NCT05905302
Last Updated: 2025-12-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Pre- and Post-Exercise
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
FE Then VE
People with Parkinson's disease (PD) who have undergone DBS surgery and utilize the Percept system completed two stationary bike exercise sessions: forced exercise (FE) and voluntary exercise (VE). FE is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. VE is standard stationary cycling. The order in which the exercise sessions were completed was randomized. This group of participants was randomized to FE as their first exercise session, and VE as their second exercise session. Participants completed the sessions OFF PD medication. The finger-tapping portion of the MDS-UPDRS III, force-tracking data, and local field potentials (LFPs) were collected before and after exercise sessions. Because all participants completed both exercise interventions, the baseline characteristics and outcome measures are reported by intervention and not by randomization.
|
VE Then FE
People with Parkinson's disease (PD) who have undergone DBS surgery and utilize the Percept system completed two stationary bike exercise sessions: forced exercise (FE) and voluntary exercise (VE). FE is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. VE is standard stationary cycling. The order in which the exercise sessions were completed was randomized. This group of participants was randomized to VE as their first exercise session, and FE as their second exercise session. Participants completed the sessions OFF PD medication. The finger-tapping portion of the MDS-UPDRS III, force-tracking data, and local field potentials (LFPs) were collected before and after exercise sessions. Because all participants completed both exercise interventions, the baseline characteristics and outcome measures are reported by intervention and not by randomization.
|
|---|---|---|
|
First Intervention (1 day)
STARTED
|
8
|
7
|
|
First Intervention (1 day)
COMPLETED
|
8
|
7
|
|
First Intervention (1 day)
NOT COMPLETED
|
0
|
0
|
|
Washout (at least 1 day)
STARTED
|
8
|
7
|
|
Washout (at least 1 day)
COMPLETED
|
8
|
7
|
|
Washout (at least 1 day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 day)
STARTED
|
8
|
7
|
|
Second Intervention (1 day)
COMPLETED
|
8
|
7
|
|
Second Intervention (1 day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Exercise on Subthalamic Nucleus Neural Activity in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=15 Participants
People with Parkinson's disease (PD) who have undergone DBS surgery and utilize the Percept system completed two stationary bike exercise sessions: forced exercise (FE) and voluntary exercise (VE). FE is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. VE is standard stationary cycling. The order in which the exercise sessions were completed was randomized. Participants completed the sessions OFF PD medication. The finger-tapping portion of the MDS-UPDRS III, force-tracking data, and local field potentials (LFPs) were collected before and after exercise sessions.
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 4.8 • n=68 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=68 Participants
|
|
Duration of Parkinson's disease
|
9.2 years
STANDARD_DEVIATION 3.8 • n=68 Participants
|
|
Time since DBS placement
|
1.5 years
n=68 Participants
|
PRIMARY outcome
Timeframe: Pre- and Post-ExerciseFinger 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.
Outcome measures
| Measure |
Experimental Arm
n=15 Participants
People with Parkinson's disease (PD) who have undergone DBS surgery and utilize the Percept system completed two stationary bike exercise sessions: forced exercise (FE) and voluntary exercise (VE). FE is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. VE is standard stationary cycling. The order in which the exercise sessions were completed was randomized. Participants completed the sessions OFF PD medication. The finger-tapping portion of the MDS-UPDRS III, force-tracking data, and local field potentials (LFPs) were collected before and after exercise sessions.
|
|---|---|
|
Finger Tapping
ON DBS
|
3 score on a scale
Interval 2.0 to 3.0
|
|
Finger Tapping
Pre-FE OFF DBS
|
3 score on a scale
Interval 3.0 to 4.0
|
|
Finger Tapping
Post-FE OFF DBS
|
3 score on a scale
Interval 2.5 to 3.5
|
|
Finger Tapping
Pre-VE OFF DBS
|
3 score on a scale
Interval 3.0 to 4.0
|
|
Finger Tapping
Post-VE OFF DBS
|
3 score on a scale
Interval 2.5 to 3.0
|
PRIMARY outcome
Timeframe: Pre- and Post-ExercisePopulation: Due to a technology error, data is unavailable for the first 2 participants. Complete data is available for 13 participants
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.
Outcome measures
| Measure |
Experimental Arm
n=13 Participants
People with Parkinson's disease (PD) who have undergone DBS surgery and utilize the Percept system completed two stationary bike exercise sessions: forced exercise (FE) and voluntary exercise (VE). FE is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. VE is standard stationary cycling. The order in which the exercise sessions were completed was randomized. Participants completed the sessions OFF PD medication. The finger-tapping portion of the MDS-UPDRS III, force-tracking data, and local field potentials (LFPs) were collected before and after exercise sessions.
|
|---|---|
|
Force Tracking
Post-FE OFF DBS
|
41.5 percentage of time within range
Standard Deviation 21.4
|
|
Force Tracking
ON DBS
|
43.3 percentage of time within range
Standard Deviation 23.5
|
|
Force Tracking
Pre-FE OFF DBS
|
44.9 percentage of time within range
Standard Deviation 20.4
|
|
Force Tracking
Pre-VE OFF DBS
|
43.0 percentage of time within range
Standard Deviation 16.5
|
|
Force Tracking
Post-VE OFF DBS
|
41.9 percentage of time within range
Standard Deviation 16.3
|
PRIMARY outcome
Timeframe: Pre- and Post-ExercisePopulation: All 15 participants (30 exercise sessions, 1 FE and 1 VE per participant) were included in the analysis, but only 28 of the 30 total exercise sessions were included due to a technology error during 2 of the sessions.
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.
Outcome measures
| Measure |
Experimental Arm
n=15 Participants
People with Parkinson's disease (PD) who have undergone DBS surgery and utilize the Percept system completed two stationary bike exercise sessions: forced exercise (FE) and voluntary exercise (VE). FE is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. VE is standard stationary cycling. The order in which the exercise sessions were completed was randomized. Participants completed the sessions OFF PD medication. The finger-tapping portion of the MDS-UPDRS III, force-tracking data, and local field potentials (LFPs) were collected before and after exercise sessions.
|
|---|---|
|
Local Field Potential
Pre-FE OFF DBS Left STN
|
100.0 percent power relative to baseline
Standard Deviation 0.0
|
|
Local Field Potential
Pre-FE OFF DBS Right STN
|
100.0 percent power relative to baseline
Standard Deviation 0.0
|
|
Local Field Potential
Post-FE OFF DBS Left STN
|
131.0 percent power relative to baseline
Standard Deviation 38.3
|
|
Local Field Potential
Post-FE OFF DBS Right STN
|
120.5 percent power relative to baseline
Standard Deviation 34.0
|
|
Local Field Potential
Pre-VE OFF DBS Left STN
|
100.0 percent power relative to baseline
Standard Deviation 0.0
|
|
Local Field Potential
Pre-VE OFF DBS Right STN
|
100.0 percent power relative to baseline
Standard Deviation 0.0
|
|
Local Field Potential
Post-VE OFF DBS Left STN
|
118.8 percent power relative to baseline
Standard Deviation 27.2
|
|
Local Field Potential
Post-VE OFF DBS Right STN
|
110.8 percent power relative to baseline
Standard Deviation 27.7
|
Adverse Events
Pre-FE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-FE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-VE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-VE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place