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NCT04953559 · ClinicalTrials.gov registry record · NA
Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep
A NA study of Insomnia, Primary, sponsored by University of Arizona.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04953559 is a NA study of Insomnia, Primary that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04953559, a NA study of Insomnia, Primary, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Insomnia is generally believed to be caused by excessive arousal of the brain and body. Rather than transitioning normally and quickly from wakefulness to sleep, individuals with insomnia tend to enter into a self-perpetuating cycle of self-referential thought and arousal. Brain imaging research has shown that these same internally focused self-reflective thoughts tend to activate a core system in the brain known as the Default Mode Network (DMN). The DMN is usually active when a person is internally focused, such as during daydreaming or mind wandering, but tends to be deactivated when the brain is focused on the external environment. The investigators hypothesize that excess activation and connectivity of this brain network may perpetuate internal conversations, worry, and rumination, preventing individuals with insomnia from falling asleep quickly and remaining asleep. Therefore, the goal of the present study is to use a brain stimulation technique known as transcranial magnetic stimulation (TMS) to target the DMN and slightly reduce its activation before bed. This should result in an easier time falling asleep. For this study, the investigators will recruit 20 healthy individuals and have them sleep in the lab on two occasions. On one occasion, they will be stimulated with a type of TMS called continuous theta burst stimulation (cTBS), which will be targeted toward their DMN. They will then try to sleep in the lab while the investigators record their brain waves using a technique known as polysomnography (PSG). On the other occasion, these same individuals will undergo the same procedure, but the TMS machine will be in a deactivated mode to present a "sham" stimulation. Participants will again try to sleep in the lab following the sham treatment while being recorded with PSG. Neither the participants nor the experimenters will know which condition the participant is receiving at the time. This will only be revealed later. Additionally, all participants will rec
Conditions Studied
Interventions
- DEVICE Active cTBS
- DEVICE Sham cTBS
Study Locations (1)
Arizona
- University of Arizona Psychiatry Department - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04953559
The ClinicalTrials.gov registry entry for NCT04953559 describes a study currently listed as 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. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Insomnia, Primary appearing as the primary indexed condition, and to 2 interventions - of which Active cTBS is the first listed.
NCT04953559 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT04953559 about?
NCT04953559 is a clinical study titled "Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep". Insomnia is generally believed to be caused by excessive arousal of the brain and body. Rather than transitioning normally and quickly from wakefulness to sleep, individuals with insomnia tend to enter into a self-perpetuating cycle of self-referential thought and arousal. Brain imaging research has...
What is the current status of trial NCT04953559?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2021-08-06. Estimated completion is 2022-08-31.
What conditions does trial NCT04953559 study?
This clinical trial studies the following conditions: Insomnia, Primary.
What interventions are being tested in trial NCT04953559?
The interventions under investigation include: Active cTBS (DEVICE), Sham cTBS (DEVICE).
Who is sponsoring clinical trial NCT04953559?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04953559 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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