Novel Paradigms of Deep Brain Stimulation for Movement Disorders
1 other identifier
interventional
16
1 country
1
Brief Summary
Investigators will enroll patients who are already selected to undergo deep brain stimulation surgery based on standard of care. The surgical implantation of the leads will be based on standard of care and will be completed with FDA-approved leads that are routinely used at Cleveland Clinic. The pulse generators (i.e. the battery) will also be standard. The research will characterize spontaneous and task-related changes in brain activity recorded from these regions alone and in relation to novel paradigms / settings of stimulation to learn how such paradigms impact both the symptoms of patients with Parkinson's disease and the underlying neural activity of the target brain region. Of particular interest is to learn if the novel paradigms of stimulation will have a lower impact on cognitive function than current settings of stimulation.To date, current DBS settings are continuous. That is, stimulation runs at approximately 200 pulses per second, all day long, day and night. The novel settings that investigators will study are part of a translational pipeline at Cleveland Clinic. Dr. Ken Baker and Dr. Machado are partners in the lab and in clinical research. Dr. Baker has completed preclinical research that has shown that it is possible to achieve excellent relief of parkinsonian symptoms with intermittent types of stimulation known as coordinated reset. In other words, Dr Baker found that using a lower dose of stimulation in an intermittent fashion can maintain the same level of symptom control. Furthermore, a lower dose of stimulation could have less effects on cognitive symptoms. In order to test these novel paradigms of stimulation, investigators will study patients immediately after DBS and over time. The immediate research will be done starting on the third day after implantation of the DBS lead(s), having the systems externalized for nine days. The long-term research will be conducted with patients already fully implanted and healed from surgery. In addition to evaluating for motor and cognitive tasks using computer based assessments, investigators will utilize non-invasive electrophysiological measures including EEG, EMG, MEG, and wearable accelerometer/gyroscopes to better characterize the effects of stimulation settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Jan 2020
Longer than P75 for not_applicable parkinson-disease
1 active site
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
Study Start
First participant enrolled
January 17, 2020
CompletedFirst Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2023
CompletedSeptember 29, 2025
October 1, 2023
3.6 years
April 22, 2020
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Upper extremity motor speed
Patients will complete arm movements in response to cues presented on a computer. The speed of movements will be compared between novel and therapeutic stimulation
Post operative externalization days 1 through 9
Verbal Fluency
Change in the number words that patients generate to letter or semantic category cues will be compared between novel and therapeutic stimulation
Post operative externalization days 1 through 9
Secondary Outcomes (7)
Cognitive Reaction Time
Post operative externalization days 1 through 9
EEG - sensorimotor evoked potentials
Post operative externalization days 1 through 9
EEG - Oscillatory activity
Post operative externalization days 1 through 9
EMG
Post operative externalization days 1 through 9
fMRI - Bold response
Post operative externalization days 1 through 9
- +2 more secondary outcomes
Study Arms (1)
Novel stimulation
OTHERAll subjects will undergo periods of stimulation using novel stimulation patterns
Interventions
Stimulation patterns will vary from the standard therapeutic approach in terms of frequency, contact location, and/or temporal pattern.
Eligibility Criteria
You may qualify if:
- diagnosis of idiopathic Parkinson's disease for greater than 3 years
- determined appropriate for deep brain stimulation surgery
- able to give consent
You may not qualify if:
- secondary Parkinson's disease, stroke, progressive central nervous system disease
- dementia that disallows the subject ability to consent
- current alcohol or substance abuse
- hearing or visual impairment precluding cognitive or sensory testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Cleveland Cliniclead
- Farmer Foundationcollaborator
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kenneth Baker, PhD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Investigator
Study Record Dates
First Submitted
April 22, 2020
First Posted
September 24, 2020
Study Start
January 17, 2020
Primary Completion
September 7, 2023
Study Completion
September 7, 2023
Last Updated
September 29, 2025
Record last verified: 2023-10