Transcranial Magnetic Stimulation for Insomnia

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arizona

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals suffering from insomnia. Participants must pass an initial screening, including a psychological interview and at-home sleep monitoring. They should be willing to undergo physical exams, wear sleep monitors nightly, and attend 10 lab visits over two-to-three weeks for treatment sessions.

Participant Groups

The study tests if transcranial magnetic stimulation (TMS) can improve sleep in insomniacs by administering it repeatedly over two weeks. It compares the effects of TMS on different brain areas versus sham (inactive) stimulation to see which leads to better long-term sleep improvements.

4Treatment groups

Active Control

Placebo Group

Group I: Active Stimulation - Posterior Cingulate CortexActive Control1 Intervention

Active Stimulation targeted at the Posterior Cingulate Cortex

Group II: Active Stimulation - Inferior Parietal LobuleActive Control1 Intervention

Active Stimulation targeted at the Inferior Parietal Lobule

Group III: Active Stimulation - Dorsomedial Prefrontal CortexActive Control1 Intervention

Active Stimulation targeted at the Dorsomedial Prefrontal Cortex

Group IV: Sham StimulationPlacebo Group1 Intervention

The TMS device will be placed to the head but no energy will be emitted.

Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications: