UAB WHARF at Lakeshore
Homewood, Alabama, 35294, United States
NCT Number: NCT07725315
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 opening soon.
Get Notified30 year–80 year
All sexes
Interventional
Not applicable
Homewood, Alabama, 35294, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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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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.
Time frame: From enrollment to end of study will be 4-5 months
Individuals will report retrospective falls and prospective falls after DBS surgery
Time frame: From enrollment to end of participation will be about 4-5 months
Free living activity prior to and after DBS surgery
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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