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NCT04922411 · ClinicalTrials.gov registry record · NA
Cortical Network Modulation by Subthalamic Nucleus DBS
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
NCT04922411 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 49 participants.
The verdict
NCT04922411, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
Study Summary
Deep brain stimulation of the subthalamic nucleus (STN DBS) in Parkinson's disease (PD) can provide substantial motor benefit yet can also produce unwanted mood and cognitive side effects. Although the neural mechanisms underlying benefits and side effects are not well understood, current hypotheses center on the potentially measurable yet currently undefined effects within downstream cortical networks. Limitations of current tools have impeded attempts to assess network connectivity directly and dynamically in humans with implanted DBS; PET lacks the necessary temporal resolution while fMRI is neither optimal nor safe for patients with implanted DBS. In this proposal, to overcome these significant limitations, the investigators apply high-density diffuse optical tomography (HD-DOT) methods to investigate how STN DBS modulates cortical functional networks and behavior in PD patients. HD-DOT uses a collection of functional near-infrared spectroscopy (fNIRS) measurements, free of radiation exposure concerns, and without electrical/metal artifacts or contraindications or safety concerns for DBS. However, common fNIRS systems are critically hampered by typically sparse measurement distributions that lead to poor anatomical specificity, unreliable image quality due to crosstalk with scalp signals, poor spatial resolution, limited field of view, unstable point spread functions, and uneven spatial coverage. HD-DOT solves these problems by using high-density interlaced source and detector imaging arrays that support densely overlapping measurements and anatomical head models that together result in higher spatial resolution, stable point spread functions, and greatly improved isolation of brain signals from scalp signals. The investigators have demonstrated that HD-DOT accurately maps functional connectivity (FC) within and between cortical resting state networks (RSNs) in the outer \~1cm of cortex with comparable temporal and spatial resolution to fMRI. Preliminary data in
Interventions
- DEVICE STN DBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-04-23 |
| Est. Completion | 2025-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04922411
The ClinicalTrials.gov registry entry for NCT04922411 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which STN DBS is the first listed.
NCT04922411 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04922411 about?
NCT04922411 is a clinical study titled "Cortical Network Modulation by Subthalamic Nucleus DBS". Deep brain stimulation of the subthalamic nucleus (STN DBS) in Parkinson's disease (PD) can provide substantial motor benefit yet can also produce unwanted mood and cognitive side effects. Although the neural mechanisms underlying benefits and side effects are not well understood, current hypotheses...
What is the current status of trial NCT04922411?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2021-04-23. Estimated completion is 2025-04-01.
What interventions are being tested in trial NCT04922411?
The interventions under investigation include: STN DBS (DEVICE).
Who is sponsoring clinical trial NCT04922411?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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