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NCT Number: NCT02569021

Battery-preserving Stimulation Patterns for Deep Brain Stimulation

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.

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Key information

Conditions

Parkinsons Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Essential Tremor Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biphasic DBS stimulation

Device

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.

  • Current best/optimized DBS setting (considered "baseline")
  • DBS off for 30 minutes as a washout period
  • Biphasic pulse stimulation mode (assessment at 0.5hr)
  • Biphasic pulse stimulation mode (assessment at 1hr)
  • Biphasic pulse stimulation mode (assessment at 2hr)
  • Biphasic pulse stimulation mode (assessment at 3hr)

Unified Parkinson's Disease Rating Scale

Other

UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease.

Other names: UPDRS

Tremor Rating Scale

Other

TRS is used by neurologists to rate the severity of a tremor.

Other names: TRS

Kinesia accelerometer

Device

The kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants.

Trigno wireless system

Device

The Trigno system measure muscle contractions.

GaitRite walking assessment.

Other

GaitRite records a patients gait pattern.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2015
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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