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Battery-preserving Stimulation Patterns for Deep Brain Stimulation

Completed
Conditions
Essential Tremor
Parkinsons Disease
Interventions
Device: Biphasic DBS stimulation
Other: Unified Parkinson's Disease Rating Scale
Other: Tremor Rating Scale
Device: Kinesia accelerometer
Device: Trigno wireless system
Other: GaitRite walking assessment.
Registration Number
NCT02569021
Lead Sponsor
University of Florida
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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)
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Exclusion Criteria
  • Other neurological diagnoses (co-existent Alzheimer's or ALS)
  • No Deep brain stimulation (DBS)
  • less than 4 Deep brain stimulation (DBS) programming
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Biphasic DBS stimulationsTremor Rating ScaleSubjects 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.
Biphasic DBS stimulationsKinesia accelerometerSubjects 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.
Biphasic DBS stimulationsGaitRite walking assessment.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.
Biphasic DBS stimulationsUnified Parkinson's Disease Rating ScaleSubjects 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.
Biphasic DBS stimulationsBiphasic DBS stimulationSubjects 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.
Biphasic DBS stimulationsTrigno wireless systemSubjects 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.
Primary Outcome Measures
NameTimeMethod
Evaluate the efficacy of novel stimulation patterns by the Tremor Rating ScaleBaseline to Day 1

Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity. The subjet will be videotaped and two raters blinded to conditions will score the TRS.

Kinesia accelerometer to measure motor dysfunctionBaseline to Day 1

The Kinesia system includes a unit worn by the subject and software that is used to collect, manage, and analyze data. The system measures three-dimensional motion using three orthogonal accelerometers and three orthogonal gyroscopes located in the sensor module.The digital data is received by the Receiver connected to a computer and processed by the Kinesia software package.

Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating ScaleBaseline to Day 1

The Unified Parkinson's Disease Rating Scale (UPDRS) is used by neurologists to rate the motor impairment of people with Parkinson's Disease. The rater obtains the score by observation and questioning the participant. Higher scores represent greater impairment and scores range from 0-108. The subject will be videotaped and two raters blinded to conditions will score the UPDRS.

Trigno wireless system to measure motor dysfunctionBaseline to Day 1

This system has sensors with a multi-function design and therefore along with recording of surface EMG signal, it allows Triaxial Accelerometry. This wireless EMG machine will measure muscle contractions.

GaitRite walking assessment.Baseline to Day 1

The GaitRite is an automated floor that when the subjects walk on the floor it records the gait pattern.

Secondary Outcome Measures
NameTimeMethod
Battery Consumption compared between pre and post settingsBaseline to Day 1

Battery consumption will be calculated and compared between the new settings and subjects' baseline settings. The Medtronic battery estimator helpline will be used to calculate battery life, as well as the University of Florida calculator.

Trial Locations

Locations (1)

Center for Movement Disorders and Neurorestoration

🇺🇸

Gainesville, Florida, United States

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