Kinematic and Neural Dynamics of Postural Instability in Parkinson's Disease

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ 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

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

Locations
United States
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
Contact Information
Primary
Robert A McGovern
Robert.McgovernIII@va.gov
(612) 629-7904
Backup
Nicole Walker, MS
nicole.walker6@va.gov
(612) 467-3229
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 100
Treatments
PD-Postural Instability
Veterans with postural instability
Sponsors
Leads: VA Office of Research and Development
Collaborators: University of Minnesota

This content was sourced from clinicaltrials.gov