Battery-preserving Stimulation Patterns for Deep Brain Stimulation

October 21, 2016 updated by: University of Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • Center for Movement Disorders and Neurorestoration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • UPDRS
Other: Tremor Rating Scale
TRS is used by neurologists to rate the severity of a tremor.
Other Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Day 1
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.
Baseline to Day 1
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.
Baseline to Day 1
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.
Baseline to Day 1
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.
Baseline to Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Micheal Okun, M.D., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201501030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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