Battery-preserving Stimulation Patterns for Deep Brain Stimulation
NCT ID: NCT02569021
Last Updated: 2016-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2014-05-31
2016-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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)
Unified Parkinson's Disease Rating Scale
UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease.
Tremor Rating Scale
TRS is used by neurologists to rate the severity of a tremor.
Kinesia accelerometer
The kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants.
Trigno wireless system
The Trigno system measure muscle contractions.
GaitRite walking assessment.
GaitRite records a patients gait pattern.
Interventions
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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)
Unified Parkinson's Disease Rating Scale
UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease.
Tremor Rating Scale
TRS is used by neurologists to rate the severity of a tremor.
Kinesia accelerometer
The kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants.
Trigno wireless system
The Trigno system measure muscle contractions.
GaitRite walking assessment.
GaitRite records a patients gait pattern.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Deep brain stimulation (DBS) already implanted
* Optimized Deep brain stimulation (DBS) settings (or at least 4 months of DBS programming)
Exclusion Criteria
* No Deep brain stimulation (DBS)
* less than 4 Deep brain stimulation (DBS) programming
18 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Micheal Okun, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201501030
Identifier Type: -
Identifier Source: org_study_id
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