Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06405334

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Balance problems and falls are among the most common complaints in Veterans with Parkinson's Disease (PD), but there are no effective treatments and the ability to measure balance and falls remains quite poor. This study uses wearable sensors to measure balance and uses deep brain stimulation electrodes to measure electric signals from the brain in Veterans with PD. The investigators hope to use this data to better understand the brain pathways underlying balance problems in PD so that new treatments to improve balance and reduce falls in Veterans with PD can be designed.

Conditions

Parkinson's Disease

Study ID

NCT06405334

Start date

Nov 1, 2024

Status verified date

Oct, 2025

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Aims 1 and 2 Inclusion criteria:

  • All Veterans with a clinical diagnosis of Parkinson's disease as made by their treating neurologist in Hoehn and Yahr stage 2-3 with the ability to give informed consent will be considered for possible participation in this study.
  • Veterans cannot be past stage 3 as our measures depend on physical independence and fall risk prediction is less useful after stage 3.
  • Capacity to consent will be assessed with the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).

  • A score of less than 14.5 will be used as the cut-off to decide whether a Veteran is capable of consenting as the false positive rate is zero below this score with marginal increases in sensitivity above this score (89% sensitivity, 100% specificity).

Aim 3

Inclusion criteria:

  • In addition to the inclusion criteria for Aims 1 and 2, Veterans with an implanted STN DBS lead with a Percept device in place.

Exclusion Criteria:

Aims 1 and 2 Exclusion criteria:

  • Veterans with dementia of sufficient severity to impair their ability to make healthcare related decisions for themselves will be excluded.
  • Veterans with other forms of parkinsonism (PSP, CBGD, etc.) will be excluded.
  • Veterans past H\&Y Stage 3 will be excluded.
  • Veterans with symptomatic orthostatic hypotension (defined as sustained drop in systolic blood pressure by 20 mmHg or diastolic blood pressure by 10 mmHg within 3 minutes of standing after being supine for five minutes) will also be excluded as this is an entity the investigators are not characterizing and could confound/bias the dataset.

Aim 3:

Exclusion criteria:

  • In addition to the exclusion criteria for Aims 1 and 2, Veterans with DBS leads implanted in other locations will be excluded.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

PD-Postural Instability

Veterans with postural instability

Primary outcome measure

  • Event Identification Receiver Operating Characteristic Curve [ Time Frame: 4 years ]
  • Silhouette Scores [ Time Frame: 4 years ]
  • Associative STN alpha band power [ Time Frame: 4 years ]
  • Postural step length response during associative STN vs. motor STN stimulation vs. no stimulation [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Robert A McGovern

(612) 629-7904Robert.McgovernIII@va.gov

Nicole Walker, MS

(612) 467-3229nicole.walker6@va.gov

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Robert A McGovern

(612) 629-7904Robert.McgovernIII@va.gov

Nicole Walker, MS

(612) 467-3229nicole.walker6@va.gov

Principal Investigator:

Robert A McGovern

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Keywords

  • Parkinson Disease
  • subthalamic nucleus
  • gait
  • postural instability
  • deep learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-03.