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Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

StatusActive, Not Recruiting
PhaseNot applicable
Started2023-07-06
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from Vanderbilt University Medical Center

Amendment history

2026-09-22
critical
Primary completion pushed: 2026-08 → 2027-08
Completion pushed: 2027-05 → 2027-08
2026-06-10
minor
Study Status v10
Primary completion date2025-07-30→2026-08
Completion date2026-05-30→2027-05
2025-12-05
minor
Study Status, Oversight v9
Completion date2025-10-30→2026-05-30
2025-10-20
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2025-08-20
minor
Study Status, Oversight, Contacts/Locations v7
Re-verified, no change to tracked fields
Show 6 earlier versions
2025-08-06
minor
Study Status, Oversight, Contacts/Locations v6
Primary completion dateestimated 2025-06-30→confirmed 2025-07-30
Completion date2025-06-30→2025-10-30
Study sitescontacts updated at 1 of 1 site
2025-03-18
minor
Study Status, Oversight, Contacts/Locations v5
Re-verified, no change to tracked fields
2025-01-21
minor
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2024-07-25
minor
Study Status, Study Design v3
Re-verified, no change to tracked fields
2024-07-24
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v2
Collaborators+35 characters
United States Department of Defense
2023-07-21
minor
Study Status, Study Design v1
Start dateestimated 2023-07-01→confirmed 2023-07-06
2023-06-27
minor
Original filing
The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.
Trial Details
NCT Number NCT05933681
Lead Sponsor Vanderbilt University Medical Center
Collaborators: United States Department of Defense
Conditions Parkinson Disease
Enrollment 160 participants
Start Date 2023-07-06
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-21