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Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation

Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation

Recruiting
30-80 years
All
Phase N/A

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Overview

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.

Description

Deep brain stimulation (DBS) is an effective 2nd line therapeutic strategy for Parkinson's disease (PD) patients in whom pharmacologic interventions no longer optimally control primary motor symptoms such as rigidity, bradykinesia, and tremor. However, the extent to which DBS improves axial motor symptoms (e.g., postural instability) is equivocal. While some investigations show improved static and dynamic balance measured in the lab, many studies also show that individuals fall at a higher rate compared to those without DBS. Increased incidence of falls reduce participation in the community. Thus, it is important to identify modifiable mechanisms of falls and design interventions that address these factors. However, in many studies investigating balance in PD, DBS is an exclusionary factor. This study addresses a major unmet need in PD therapeutics to identify causal factors that increase fall risk after DBS implantation and programming.

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria: Patient's insurance will not cover the costs of surgery with investigational devices, Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation, self-report of lack of clear levodopa response, requires a walker or wheelchair for mobility

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Study details
    Deep Brain Stimulation
    PARKINSON DISEASE (Disorder)

NCT07725315

University of Alabama at Birmingham

31 October 2026

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