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Behavioural Intervention

Active cTBS for Primary Insomnia

N/A
Recruiting
Led By William D Killgore, PhD
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 during morning of overnight visit 1 (day 9)
Awards & highlights

Summary

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.

Eligible Conditions
  • Primary Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once during cognitive testing portion of overnight visit 2 (day 15-16), day 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and once during cognitive testing portion of overnight visit 2 (day 15-16), day 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of time spent in each sleep stage following administration of active or sham cTBS TMS
Sleep efficiency (SE) following administration of active or sham cTBS TMS - day 8-9
Sleep onset latency (SOL) following administration of active or sham cTBS TMS
+8 more
Secondary study objectives
Actigraphy
California Verbal Learning Test Third Edition (CVLT-3) - day 15-16
California Verbal Learning Test Third Edition (CVLT-3) - day 8-9
+83 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham cTBS first, then active cTBSExperimental Treatment2 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 cTBSExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active cTBS
2023
N/A
~10
Sham cTBS
2016
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
525 Previous Clinical Trials
155,228 Total Patients Enrolled
William D Killgore, PhDPrincipal InvestigatorUniversity of Arizona
3 Previous Clinical Trials
150 Total Patients Enrolled
~5 spots leftby Sep 2025
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