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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 approximately one hour after previous administration during cognitive testing of overnight visit 1 (day 8-9), day 8

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately one hour after previous administration during cognitive testing on enrollment day (day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately one hour after previous administration during cognitive testing on enrollment day (day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately one hour after previous administration during cognitive testing on enrollment day (day 1) 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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