NCT02318927

A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these two brain regions after surgery will allow for the development of a personalized DBS system to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the optimized device settings.

Detailed description

As a participant in the study you will have the following procedure performed: A series of questions by interview, questionnaires, and checklists will be collected. In addition, basic information (such as age, sex, race) and psychiatric, medical, and family history, physical and neurological exam that will include measuring vital signs (heart rate and blood pressure). There will be a "Falls Diary' to complete (an account of falling incidents and the details). Specific testing will be done to evaluate the gait and balance which will be repeated throughout the study. A psychiatric evaluation of mood and emotion will be performed including a detailed psychological testing, consisting of perception, learning, and memory. These psychological assessments will be repeated at every study visit. An MRI and a CT scan will be performed to make sure of the exact location of the DBS implant. The study will end in 24 months.

Conditions

• Parkinsons Disease

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-11-03
• Completion: 2018-09-26
• First posted: 2014-12-17
• Last updated: 2018-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study