Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

Recruiting in Palo Alto (17 mi)

Overseen by William D Killgore, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a brain stimulation technique to help people with insomnia fall asleep. It targets a brain area involved in daydreaming and internal thoughts, reducing its activity before bedtime. The study aims to see if this method can improve sleep without using drugs. The procedure is non-invasive and has been studied for its potential in treating various sleep disorders.

Eligibility Criteria

Inclusion Criteria

Greater than or equal to 11 for ESS (Johns, 2000)

Healthy men and non-pregnant, non-lactating women 18-50 (inclusive) years of age, free from contraindicated diseases, medications, devices, and conditions.

Greater than or equal to 15 for ISI (Gagnon, Belanger, Ivers, & Morin, 2013)

Participant Groups

Group I: Sham cTBS first, then active cTBS Experimental Treatment 2 Interventions

Participants complete an Enrollment Visit followed by one week of at-home actigraphy. Participants return to the lab for Overnight Visit 1 and undergo a MRI scan followed by sham cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep. Participants return home and complete another week of at-home actigraphy. Participants then return to the lab for Overnight Visit 2 where they undergo a MRI scan followed by active cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep.

Group II: Active cTBS first, then sham cTBS Experimental Treatment 2 Interventions

Participants complete an Enrollment Visit followed by one week of at-home actigraphy. Participants return to the lab for Overnight Visit 1 and undergo a MRI scan followed by active cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep. Participants return home and complete another week of at-home actigraphy. Participants then return to the lab for Overnight Visit 2 where they undergo a MRI scan followed by sham cTBS and then another MRI scan followed by a night of polysomnographic monitored in-lab sleep.

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

🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

🇨🇦 Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Arizona Psychiatry Department Tucson, AZ

Who Is Running the Clinical Trial?

University of Arizona Lead Sponsor

References