Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT06631209
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) — DEVICE
    Specifically, Continual Theta Burst Stimulation
  • Sham — OTHER
    Sham TMS

Study Details

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.

Key Dates

Start date
Jun 23, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Stimulation - Posterior Cingulate Cortex
    Active Stimulation targeted at the Posterior Cingulate Cortex
  • Active Comparator: Active Stimulation - Inferior Parietal Lobule
    Active Stimulation targeted at the Inferior Parietal Lobule
  • Active Comparator: Active Stimulation - Dorsomedial Prefrontal Cortex
    Active Stimulation targeted at the Dorsomedial Prefrontal Cortex
  • Sham Comparator: Sham Stimulation
    The TMS device will be placed to the head but no energy will be emitted.

Primary Outcome Measure

Sleep stage changes as determined by Polysomnography [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SCAN LabTucsonArizona85724
William Killgore, Ph.D.
[email protected]
520-621-0605

Find similar trials in Tucson, AZ

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
SCAN Lab· Tucson, AZ

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