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Procedure

Transcranial Magnetic Stimulation for Insomnia

N/A
Waitlist Available
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months

Summary

"This trial aims to see if a certain type of brain stimulation called cTBS can help improve sleep in people with insomnia. 120 participants will be recruited for a 3-year study. They will

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The sham procedure is not expected to have any side effects as it's inactive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in DMN within-network connectivity during resting state
Change in Insomnia Severity Index (ISI) score
Change in scores on the Pre-Sleep Arousal Scale (PSAS)
+5 more
Secondary study objectives
Change in DMN activity during a cognitively demanding task
Change in Epworth Sleepiness Scale
Change in GABA levels in the posterior cingulate cortex
+29 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
536 Previous Clinical Trials
159,553 Total Patients Enrolled
5 Trials studying Insomnia
228 Patients Enrolled for Insomnia
U.S. Army Medical Research Acquisition ActivityFED
23 Previous Clinical Trials
8,273 Total Patients Enrolled
~96 spots leftby Jan 2028
Unbiased ResultsWe believe in providing patients with all the options.
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