NCT07725315

Brief Summary

The purpose of this pilot study is to assess changes in thinking and movement after deep brain stimulator implantation. The study will also examine whether these changes are related to the risk of falls.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Deep Brain StimulationPARKINSON DISEASE (Disorder)

Keywords

DBS, Parkinson's disease, Falls

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Falls

    Individuals will report retrospective falls and prospective falls after DBS surgery

    From enrollment to end of study will be 4-5 months

Secondary Outcomes (1)

  • Step count

    From enrollment to end of participation will be about 4-5 months

Study Arms (1)

DBS for standard of care

EXPERIMENTAL

Individuals who undergo DBS surgery as part of standard of care will be observed prior to and after DBS surgery and data at these timepoints associated with indicine falls.

Behavioral: DBS as part of standard of care

Interventions

DBS as part of standard of careBEHAVIORAL

Individuals with Parkinson's Disease will be selected to undergo DBS as part of standard of care. Those individuals will be assessed prior to and 3 months after.

DBS for standard of care

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30-80, patient has elected to undergo DBS surgery as part of routine care, cleared for deep brain stimulation surgery as part of routine care by the movement disorders committee. Refractory motor symptoms such as dyskinesias, wearing off, and/or motor fluctuations, causing significant disability, despite reasonable attempts at medical management, as determined by the consensus DBS committee, able to walk, Patient is available for follow-up over the length of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB WHARF at Lakeshore

Homewood, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Christopher Hurt, PhD

CONTACT

2059345817cphurt@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)