Battery-preserving Stimulation Patterns for Deep Brain Stimulation

NCT02569021 | Completed DMC

• 1 other identifier: IRB201501030
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinsons Disease; Essential Tremor

Keywords

Parkinsons Disease; Essential Tremor; DBS; Depp Brain Stimulation

Outcome Measures

Primary Outcomes (5)

• Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale

  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

  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

  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

  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.

  The GaitRite is an automated floor that when the subjects walk on the floor it records the gait pattern.

  Baseline to Day 1

Secondary Outcomes (1)

• Battery Consumption compared between pre and post settings

  Baseline to Day 1

Study Arms (1)

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; Other: Unified Parkinson's Disease Rating Scale; Other: Tremor Rating Scale; Device: Kinesia accelerometer; Device: Trigno wireless system; Other: GaitRite walking assessment.

Interventions

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. 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)

Biphasic DBS stimulations

Unified Parkinson's Disease Rating Scale OTHER

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

Also known as: UPDRS

Biphasic DBS stimulations

Tremor Rating Scale OTHER

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

Also known as: TRS

Biphasic DBS stimulations

Kinesia accelerometer DEVICE

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

Biphasic DBS stimulations

Trigno wireless system DEVICE

The Trigno system measure muscle contractions.

Biphasic DBS stimulations

GaitRite walking assessment. OTHER

GaitRite records a patients gait pattern.

Biphasic DBS stimulations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Other neurological diagnoses (co-existent Alzheimer's or ALS)
• No Deep brain stimulation (DBS)
• less than 4 Deep brain stimulation (DBS) programming

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Micheal Okun, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 6, 2015
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 24, 2016

Record last verified: 2016-10

Locations

US (1)