Battery-preserving Stimulation Patterns for Deep Brain Stimulation
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|ClinicalTrials.gov Identifier: NCT02569021|
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : October 24, 2016
|Condition or disease||Intervention/treatment|
|Parkinsons Disease Essential Tremor||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.|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Battery-preserving Stimulation Patterns to Improve Symptoms in Parkinson's Disease and Essential Tremor|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||September 2016|
Biphasic DBS stimulations
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.
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.
Other: Unified Parkinson's Disease Rating Scale
UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease.
Other Name: UPDRS
Other: Tremor Rating Scale
TRS is used by neurologists to rate the severity of a tremor.
Other Name: TRS
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.
- Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale [ Time Frame: Baseline 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.
- Evaluate the efficacy of novel stimulation patterns by the Tremor Rating Scale [ Time Frame: Baseline 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 dysfunction [ Time Frame: Baseline 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.
- Trigno wireless system to measure motor dysfunction [ Time Frame: Baseline 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. [ Time Frame: Baseline to Day 1 ]The GaitRite is an automated floor that when the subjects walk on the floor it records the gait pattern.
- Battery Consumption compared between pre and post settings [ Time Frame: Baseline 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569021
|United States, Florida|
|Center for Movement Disorders and Neurorestoration|
|Gainesville, Florida, United States, 32607|
|Principal Investigator:||Micheal Okun, M.D.||University of Florida|