Novel Paradigms of Deep Brain Stimulation for Movement Disorders
Public ClinicalTrials.gov record NCT04563143. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04563143
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2020
- Primary completion
- Sep 6, 2023
- Completion
- Sep 6, 2023
- Last update posted
- Sep 28, 2025
2020 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04563143, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2025 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04563143 live on ClinicalTrials.gov.