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: Active NA study of Parkinson Disease and Sleep Fragmentation, sponsored by University of Nebraska.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will measure pre- vs. post-stimulation impact on (1) LFP spectral composition; (2) sleep episode-specific change in duration; and (3) stimulation-induced latency to transition to next sleep episode.
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 |
What the registry record for NCT04620551 still lists
NCT04620551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Where NCT04620551's enrollment target sits among peer trials
20 241st of 297 higher than 46 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI