Battery-preserving Stimulation Patterns for Deep Brain Stimulation

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569021
• Other study ID #: IRB201501030
• Status: Completed
• Phase: N/A
• First received: October 2, 2015
• Last updated: October 21, 2016
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinsons Disease
• Tremor

Intervention

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. 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)

Other:
• 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.

Device:
• 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.

Other:
• GaitRite walking assessment.
GaitRite records a patients gait pattern.

Locations

Country	Name	City	State
United States	Center for Movement Disorders and Neurorestoration	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Battery Consumption compared between pre and post settings	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	No