Clinical trial NCT02569021: Battery-preserving Stimulation Patterns for Deep Brain Stimulation
Official title: Battery-preserving Stimulation Patterns to Improve Symptoms in Parkinson's Disease and Essential Tremor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinsons Disease
Essential Tremor
Keywords: Parkinsons Disease
Essential Tremor
DBS
Depp Brain Stimulation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited during routine DBS programming sessions at the University of Florida, Center for Movement Disorders

Brief summary: The purpose of this research study is to test effectiveness of different deep brain stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the battery. If these patterns are effective, the implanted batteries will be drained more slowly and last longer than currently expected. An increase in battery life may reduce the number of surgeries needed to replace them.

Detailed description: Deep brain stimulation (DBS) is an effective surgical therapy for medication-refractory symptoms of Parkinson's disease, tremor, and dystonia. Patients implanted with DBS experience a significant improvement of their symptoms with relatively low risk of intolerable side effects. Implanted patients must undergo repeat surgeries to replace the Implantable Pulse Generators/batteries (IPG) approximately every 2 to 5 years. The DBS program (at the University of Florida) has studied battery consumption and has been interested in potential strategies to extend the life of the IPG to reduce the need for frequent battery replacement surgeries, while improving symptom-relief, patient satisfaction, and the potential associated financial burdens.

The research study will evaluate the effects of novel stimulation patterns on tremor, bradykinesia, rigidity and gait in Parkinson's disease and essential tremor patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's disease or Essential Tremor by strict criteria
* Deep brain stimulation (DBS) already implanted
* Optimized Deep brain stimulation (DBS) settings (or at least 4 months of DBS programming)

Exclusion Criteria:

* Other neurological diagnoses (co-existent Alzheimer's or ALS)
* No Deep brain stimulation (DBS)
* less than 4 Deep brain stimulation (DBS) programming

Primary outcomes:
measure: Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale
timeFrame: Baseline to Day 1
measure: Evaluate the efficacy of novel stimulation patterns by the Tremor Rating Scale
timeFrame: Baseline to Day 1
measure: Kinesia accelerometer to measure motor dysfunction
timeFrame: Baseline to Day 1
measure: Trigno wireless system to measure motor dysfunction
timeFrame: Baseline to Day 1
measure: GaitRite walking assessment.
timeFrame: Baseline to Day 1
Secondary outcomes:
measure: Battery Consumption compared between pre and post settings
timeFrame: Baseline to Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Center for Movement Disorders and Neurorestoration
state: Florida
Study officials:
affiliation: University of Florida
name: Micheal Okun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: