Battery-preserving Stimulation Patterns for Deep Brain Stimulation

University of Florida

Status: Completed

Conditions: Essential Tremor; Parkinsons Disease

Treatments: Other: GaitRite walking assessment.; Device: Trigno wireless system; Other: Tremor Rating Scale; Device: Biphasic DBS stimulation; Other: Unified Parkinson's Disease Rating Scale; Device: Kinesia accelerometer

Study type: Observational

Funder types: Other

Identifiers

NCT02569021

IRB201501030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Biphasic DBS stimulations

Description:

Subjects in this group will have Biphasic DBS stimulation setting performed, Unified Parkinson's Disease Rating Scale (UPDRS), Tremor Rating Scale (TRS), kinesia accelerometer assessment, Trigno wireless system (EMG) assessment and GaitRite walking assessment performed.

Treatment:

Device: Trigno wireless system

Other: Unified Parkinson's Disease Rating Scale

Device: Biphasic DBS stimulation

Other: GaitRite walking assessment.

Device: Kinesia accelerometer

Other: Tremor Rating Scale