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NCT04563143 · ClinicalTrials.gov registry record · NA
Novel Paradigms of Deep Brain Stimulation for Movement Disorders
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT04563143 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 16 participants.
The verdict
NCT04563143, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study 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
Interventions
- OTHER Novel DBS Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-01-17 |
| Est. Completion | 2023-09-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04563143
The ClinicalTrials.gov registry entry for NCT04563143 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Novel DBS Stimulation is the first listed.
NCT04563143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04563143 about?
NCT04563143 is a clinical study titled "Novel Paradigms of Deep Brain Stimulation for Movement Disorders". 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 pul...
What is the current status of trial NCT04563143?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2020-01-17. Estimated completion is 2023-09-07.
What interventions are being tested in trial NCT04563143?
The interventions under investigation include: Novel DBS Stimulation (OTHER).
Who is sponsoring clinical trial NCT04563143?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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