Effects of Stimulation Patterns of Deep Brain Stimulation
2 other identifiers
interventional
180
1 country
3
Brief Summary
The purpose of this study is to measure the effects of non-regular temporal patterns of deep brain stimulation (DBS) on motor symptoms and neural activity in persons with Parkinson's disease (PD), essential tremor (ET), dystonia or multiple sclerosis (MS). These data will guide the design of novel stimulation patterns that may lead to more effective and reliable treatment with DBS. These data will also enable evaluation of current hypotheses on the mechanisms of action of DBS. Improving our understanding of the mechanisms of action of DBS may lead to full development of DBS as a treatment for Parkinson's disease and may lead to future applications of DBS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jun 2016
Longer than P75 for not_applicable parkinson-disease
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedStudy Start
First participant enrolled
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 9, 2026
April 1, 2026
10.8 years
September 15, 2015
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Tremor Accelerometry
Tremor responses to deep brain stimulation (DBS) may be recorded by an accelerometer in subjects with essential tremor (ET), multiple sclerosis (MS) and tremor-dominant Parkinson's disease (PD). Tremor will be quantified by calculating the total power within a window of the power spectrum of the time series of the tremor, and this measure will be compared across stimulation patterns.
Day 1
Bradykinesia Finger Tapping
Bradykinesia responses to deep brain stimulation (DBS) may be recorded by a computer mouse in subjects with Parkinson's disease (PD) who do not have dominant tremor symptoms. Bradykinesia will be quantified as the timing of alternating finger presses, a validated test of bradykinesia, and this measure will be compared across stimulation patterns.
Day 1
Neural Activity
Neural activity consisting of electrically evoked compound action potentials (ECAPs), DBS local evoked potentials (DLEPs) and/or local field potentials (LFPs) may be recorded in response to deep brain stimulation (DBS). Neural activity characteristics will be compared across stimulation patterns and may be correlated with changes in severity of motor symptoms (tremor or bradykinesia).
Day 1
Secondary Outcomes (1)
Electrode Location
Day 1
Study Arms (2)
Therapeutic Stimulation Patterns
EXPERIMENTALThis group will receive temporal patterns of stimulation that are designed to suppress oscillatory neural activity at theta- or beta-frequencies. These patterns are hypothesized to alleviate motor symptoms.
Symptogenic Stimulation Patterns
EXPERIMENTALThis group will receive symptogenic patterns of stimulation that are designed to exacerbate oscillatory neural activity at theta- or beta-frequencies. These patterns are hypothesized to exacerbate motor symptoms.
Interventions
During deep brain stimulation (DBS) electrode implantation or implanted pulse generator (IPG) replacement surgery, different stimulation patterns that are designed to suppress oscillatory neural activity at theta- or beta-frequencies will be delivered in randomized order, and the subject will be blinded to the patterns. Neural activity and/or motor symptoms (tremor and/or bradykinesia) will be measured in response to DBS. Measurements will be made during 2- to 8-minute trials, in which stimulation will be off for the first half of the trial, and on for the remaining half. Neural activity and/or motor symptoms will be measured during both the off and on phases. The total amount of time necessary for data collection will be about 45 minutes.
During deep brain stimulation (DBS) electrode implantation or implanted pulse generator (IPG) replacement surgery, different stimulation patterns that are designed to exacerbate oscillatory neural activity at theta- or beta-frequencies will be delivered in randomized order, and the subject will be blinded to the patterns. Neural activity and/or motor symptoms (tremor and/or bradykinesia) will be measured in response to DBS. Measurements will be made during 2- to 8-minute trials, in which stimulation will be off for the first half of the trial, and on for the remaining half. Neural activity and/or motor symptoms will be measured during both the off and on phases. The total amount of time necessary for data collection will be about 45 minutes.
Eligibility Criteria
You may qualify if:
- Diagnosis of Parkinson's Disease (PD), Essential Tremor (ET) dystonia or Multiple Sclerosis (MS)
- Scheduled to undergo Deep Brain Stimulation (DBS) electrode implant, IPG implant or implanted pulse generator (IPG) replacement surgery
- Neurologically stable
- Able to understand the study and consent form
You may not qualify if:
- Inability to execute the motor tasks during the study
- Inability to tolerate withholding anti-parkinsonian and/or anti-tremor medications
- Clinically ineffective DBS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitycollaborator
- Boston Scientific Corporationcollaborator
- University of Floridacollaborator
- Duke Universitylead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (3)
University of Florida
Gainesville, Florida, 32610, United States
Emory University
Atlanta, Georgia, 30322, United States
Duke University
Durham, North Carolina, 27708, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Warren M Grill, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 17, 2015
Study Start
June 2, 2016
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04