[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725315":3,"trial-entities:NCT07725315":81,"trial-summary:NCT07725315":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":14,"eligibility_criteria":49,"std_ages":54,"locations":57,"central_contacts":73,"overall_officials":78,"references":79,"see_also_links":80},"NCT07725315","IRB-300016843","Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation","NOT_YET_RECRUITING","2027-11-01","2026-07","2026-07-24","2026-08-01","University of Alabama at Birmingham","OTHER",false,"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.","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.",[18,19],"Deep Brain Stimulation","PARKINSON DISEASE (Disorder)",[21],"DBS, Parkinson's disease, Falls","INTERVENTIONAL","DIAGNOSTIC",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","DBS as part of standard of care","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.",[35],"DBS for standard of care",[37],{"measure":38,"description":39,"timeFrame":40},"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",[42],{"measure":43,"description":44,"timeFrame":45},"Step count","Free living activity prior to and after DBS surgery","From enrollment to end of participation will be about 4-5 months","ALL","30 Years","80 Years",{"inclusion":50,"exclusion":52,"raw_text":53},[51],"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\u002For 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",[],"Inclusion Criteria:\n\n* 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\u002For 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\n\nExclusion 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\n\n\\-",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":59,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":70},"UAB WHARF at Lakeshore","Homewood","Alabama","35294","United States",[65],{"name":66,"role":67,"phone":68,"email":69},"Alexandra Evancho, PhD","CONTACT","(205) 975-5229","amelgin@uab.edu",{"lat":71,"lon":72},33.47177,-86.80082,[74],{"name":75,"role":67,"phone":76,"email":77},"Christopher Hurt, PhD","2059345817","cphurt@uab.edu",[],[],[],{"nct_id":4,"conditions":82,"biomarkers":85},[83,84],"Fall","Parkinson Disease",[],{"nct_id":4,"found":87,"summary":88,"prompt_version":98},true,{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an interventional study planning to enroll 20 participants. It will assess individuals before and 3 months after receiving Deep Brain Stimulation (DBS) as part of their standard medical care.","completed","Investigating Fall Risk After Deep Brain Stimulation for Parkinson's Disease","This study is looking at how Deep Brain Stimulation (DBS) affects thinking, movement, and the risk of falls in people with Parkinson's disease. DBS is a treatment option for Parkinson's when medications don't fully control symptoms like stiffness, slow movement, or tremor. Researchers want to understand why some people might fall more often after DBS, even though it helps with other symptoms. You might be able to join if you are 30-80 years old, have Parkinson's disease, and have already decided to have DBS surgery as part of your regular care. The main goal is to see how many falls you report from when you join until about 4-5 months later. The study plans to enroll 20 participants, but its current status is unclear.","Participants will be followed for self-reported falls from enrollment until the end of the study, which will be 4-5 months after joining.",124,"You will be assessed before your Deep Brain Stimulation (DBS) surgery and again 3 months after the surgery. The total study duration from enrollment to end will be 4-5 months.","Not stated in the trial record.",[],"v2"]