Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04620551 · ClinicalTrials.gov registry record · NA
Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease
A NA study of Parkinson Disease and Sleep Fragmentation, sponsored by University of Nebraska.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04620551 is a NA study of Parkinson Disease and Sleep Fragmentation that is active but no longer recruiting, run by University of Nebraska. The registered enrollment target is 20 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04620551, a NA study of Parkinson Disease and Sleep Fragmentation, is active but no longer recruiting, sponsored by University of Nebraska.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.
Conditions Studied
Interventions
- DEVICE Sub-clinical stimulation
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04620551
The ClinicalTrials.gov registry entry for NCT04620551 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 1 intervention - of which Sub-clinical stimulation is the first listed.
NCT04620551 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT04620551 about?
NCT04620551 is a clinical study titled "Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease". Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidi...
What is the current status of trial NCT04620551?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2020-10-21. Estimated completion is 2026-06.
What conditions does trial NCT04620551 study?
This clinical trial studies the following conditions: Parkinson Disease, Sleep Fragmentation.
What interventions are being tested in trial NCT04620551?
The interventions under investigation include: Sub-clinical stimulation (DEVICE).
Who is sponsoring clinical trial NCT04620551?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04620551 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease
RECRUITING · NA
-
Neocortical Microarchitecture of Executive Function
RECRUITING · NA
-
Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)
RECRUITING · NA
-
Neurophysiology of Reward Signaling in Parkinson's Disease
RECRUITING · NA
-
Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease
RECRUITING · NA
-
Rock Steady Boxing: A Community Based In Person Class
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.