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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
Sponsor:
Information provided by (Responsible Party):
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.

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.

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

  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 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited during routine DBS programming sessions at the University of Florida, Center for Movement Disorders
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Florida
Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Micheal Okun, M.D. University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02569021    
Other Study ID Numbers: IRB201501030
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Keywords provided by University of Florida:
Parkinsons Disease
Essential Tremor
DBS
Depp Brain Stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations