NCT02569021

Battery-preserving Stimulation Patterns for Deep Brain Stimulation

Battery-preserving Stimulation Patterns to Improve Symptoms in Parkinson's Disease and Essential Tremor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinsons Disease
• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Biphasic DBS stimulation	The following protocol will be followed for each subject. In between, baseline and novel stimulation settings there will be a 30-minute washout period with DBS in the off state. 1. Current best/optimized DBS setting (considered "baseline") 2. DBS off for 30 minutes as a washout period 3. Biphasic pulse stimulation mode (assessment at 0.5hr) 4. Biphasic pulse stimulation mode (assessment at 1hr) 5. Biphasic pulse stimulation mode (assessment at 2hr) 6. Biphasic pulse stimulation mode (assessment at 3hr)
OTHER	Unified Parkinson's Disease Rating Scale	UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease.
OTHER	Tremor Rating Scale	TRS is used by neurologists to rate the severity of a tremor.
DEVICE	Kinesia accelerometer	The kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants.
DEVICE	Trigno wireless system	The Trigno system measure muscle contractions.
OTHER	GaitRite walking assessment.	GaitRite records a patients gait pattern.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-04-01
• Completion: 2016-09-01
• First posted: 2015-10-06
• Last updated: 2016-10-24

Locations

1 site across 1 country: United States