Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
University of Arizona
Summary
The investigators propose to expand our previous work to test whether 10 repeated administrations of the cTBS procedure over a two-week period can lead to longer-term improvements in sleep, perhaps up to 3-months. For this 3-year study, 120 people with insomnia will be recruited to participate. There will be an initial screening, with the first consent form being for the screening questions, a psychological interview, and a one night at home sleep monitoring session with our equipment. If participants pass this first phase, they will reconsent for the main portion of the study. They will then undergo a physical examination, then a week-long at-home monitoring phase where they will wear a wristwatch sleep monitor as well as wear a portable brain wave monitor to bed each night to record sleep. Participants will continue to use this equipment throughout the treatment phase and for one week post treatment. After the first monitoring phase, each participant will be randomly assigned to one of four different conditions (i.e., 30 assigned to each group). Three of the conditions will involve cTBS focused on different brain locations (i.e., stimulation to the middle front, middle back, or side of the skull), while the fourth condition will provide inactive sham stimulation as a control. All participants will complete 10 treatment visits to the lab over two-to-three weeks, during which they will get a brief cTBS or sham stimulation each time. In addition, all participants will complete a brain scanning and cognitive testing session at the beginning and end of the two-to-three week treatment period. Participants will also complete 1-month and 3-month online follow-up assessments to examine long-term effects.
Description
Phase 0: Screening and Rule-Outs: During the REDCap Screening, participants will first read this informed consent form and sign it electronically on REDCap to proceed. To begin the screening questions, they must pass a 10-question comprehension check with questions regarding this document to ensure you understand the study. They will then answer a series of questionnaires related to demographics and health background. The REDCap screener will automatically end the survey if they indicate any exclusion. If you are included in the study, at the end of the screening questions it will indicate so…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy men and non-pregnant women 18-60 (inclusive) years of age free from contraindicated diseases, medications, devices, and conditions. * Must score in the moderate or higher range on the Insomnia Severity Index (ISI ≥ 15) * Must meet the criteria for DSM-5 insomnia disorder as determined by a clinical interview with a board-certified sleep medicine physician. * Sex ratio will be set to \~50% males; \~50% females * Ethnicity ratio will be set to \~29.5% who identify as a minority; \~70.5% who identify as white Exclusion Criteria: * Presence of any metal implant or…
Interventions
- DeviceTranscranial Magnetic Stimulation (TMS)
Specifically, Continual Theta Burst Stimulation
- OtherSham
Sham TMS
Location
- SCAN LabTucson, Arizona