rTMS for Insomnia

(TREAT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Repetitive transcranial magnetic stimulation (rTMS) has shown to be a promising technique for improving insomnia symptoms and sleep quality. However, the impact of circadian rhythmicity on rTMS sessions and its potential influence on insomnia therapy remains unclear. Moreover, the effect of rTMS on objective sleep parameters is not fully established. The objective of this pilot study is to establish key feasibility and preliminary data that would be used for an R-level grant application focused on optimizing rTMS therapy for insomnia. The investigators will acquire feasibility data from ten adults with Insomnia disorder. Participants will receive ten sessions rTMS over two weeks, either in the morning or evening. Sleep parameters will be assessed before, during, and after completion of rTMS and brain cortical excitability will be collected before rTMS treatment. The investigators aim to 1) evaluate the impact of circadian timing of rTMS sessions on subjective and objective sleep outcomes, 2) assess the time course of improvements in sleep outcomes, and 3) examine the association between sleep outcomes and cortical excitability. The overarching goal of this work is to optimize rTMS therapy for insomnia by investigating the impact of circadian timing on rTMS sessions and assessing potential variations in subjective and objective measures of sleep.

Eligibility Criteria

This trial is for adults with Insomnia disorder. It aims to gather preliminary data on how well rTMS, a non-invasive brain stimulation technique, can improve sleep quality when given at different times of the day.

Inclusion Criteria

Fluent and literate in English

Written, informed consent

Reside within 60 miles of Stanford University

Exclusion Criteria

Presence of other sleep or circadian rhythm disorders that significantly contribute to their sleep disturbance. The presence of these disorders will be assessed by the DUKE structured interview for sleep disorders.

Individuals who were high risk for sleep apnea on the Berlin Questionnaire and are not CPAP adherent

Excessive alcohol consumption (>14 drinks per week or > 4 drinks per occasion)

Participant Groups

The study tests if the timing of rTMS sessions (morning or evening) affects sleep improvement in insomnia patients. Participants will undergo ten rTMS treatments over two weeks and have their sleep and brain activity measured before and after therapy.

Group I: MORNING GROUP Experimental Treatment 1 Intervention

Five participants (21 to 45 years old) experiencing clinically meaningful insomnia symptoms will be enrolled and will receive 10 sessions of right dorsolateral prefrontal cortex (DLPFC) rTMS therapy in the morning over two consecutive weeks.

Group II: EVENING GROUP Experimental Treatment 1 Intervention

Five participants (21 to 45 years old) experiencing clinically meaningful insomnia symptoms will be enrolled and will receive 10 sessions of right dorsolateral prefrontal cortex (DLPFC) rTMS therapy in the evening over two consecutive weeks.

Repeated Transcranial Magnetic Stimulation (rTMS) is already approved in United States, Canada for the following indications:

🇺🇸 Approved in United States as rTMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Chronic Pain Syndrome
• Smoking Cessation

🇨🇦 Approved in Canada as rTMS for:

• Major Depressive Disorder (MDD)
• Chronic Pain Syndrome

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

1070 Arastradero Road Palo Alto, CA

Who Is Running the Clinical Trial?

Stanford University Lead Sponsor

References