โš ๏ธ Medical Notice: If you are experiencing a medical emergency, call 911 or go to the nearest ER. This directory is an educational resource and not an emergency medical service.
๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2022-08-17)

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

๐ŸŸข Recruiting Protocol / Phase N/A โš™๏ธ Medical Device Protocol Sponsor: University of Arizona

๐Ÿฉบ Protocol 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 receive a brain scan just before and just after the TMS procedures so that the investigators can examine changes in brain connectivity and chemistry. The investigators expect that the participants will sleep better following the cTBS than following the sham condition and that this will be associated with measurable differences in their brain connectivity and brain chemistry. If effective, this project would have identified an innovative and novel approach for improving sleep without using drugs.

Primary Research Facility: University of Arizona Psychiatry Department (Tucson, Arizona)

๐Ÿ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

๐Ÿ“ Primary Site Map

Site: University of Arizona Psychiatry Department โ€” Tucson, Arizona

๐Ÿ“„ Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT04953559 โ€ข Last Synced: 2022-08-17
View on ClinicalTrials.gov โ†—
๐Ÿ“ž Call Desk ๐Ÿ“‹ Check Criteria