rTMS for Insomnia Treatment Timing

This study is looking at how the timing of repetitive transcranial magnetic stimulation (rTMS) affects its ability to improve insomnia. rTMS uses magnetic pulses to gently stimulate parts of the brain. Researchers want to see if receiving rTMS in the morning or evening makes a difference for people with insomnia. They will measure changes in your insomnia symptoms using questionnaires like the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) before and after treatment. This is a small pilot study with 10 participants to gather initial information for future research. You may be able to join if you are 25-45 years old, have an insomnia diagnosis, and live near Stanford University.

Study design
This is an interventional study with 10 participants. It is a pilot study to gather preliminary data.
What's involved
You would receive ten sessions of rTMS over two weeks, either in the morning or evening. Insomnia questionnaires will be completed before and after these sessions.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia symptoms will be measured within one week before and within one week after the two-week rTMS therapy.

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NCT06656533

Optimizing the Timing of rTMS to Enhance the Administration of Insomnia Treatment

Recruiting
NAAges 25–45InterventionalTreatment
Stanford University
~10 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Repeated Transcranial magnetic stimulation (rTMS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index (ISI)
Measured over Insomnia severity index will be collected within one week before and within one week after the 10 sessions (over two weeks) of rTMS therapy.
+1 more outcome measured
Insomnia
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

Males and females of any racial or ethnic group, aged 25-45 (inclusive)
Insomnia diagnosis via the DUKE
Fluent and literate in English
Written, informed consent
Reside within 60 miles of Stanford University

Exclusion

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.
No regular use of benzodiazepine, opiate, thyroid, anticonvulsant or antipsychotic medications
Use of psychotropic medications that would significantly impact sleep, alertness, and no illicit drugs.
Excessive alcohol consumption (\>14 drinks per week or \> 4 drinks per occasion)
Presence of suicidal ideations representing elevated risk as determined by the Beck Depression Inventory (score of \> 0 on BDI question #9).
History of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, head trauma with loss of consciousness greater than thirty minutes.
Substance abuse or dependence
History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities OR traumatic brain injury in the past two months
Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
Pregnant or breast feeding
Current or lifetime history of bipolar disorder, PTSD or psychosis or current depression
Received cognitive behavioral therapy for insomnia within the past year
Current exposure to trauma, or exposure to trauma within the past 3 months
Working a rotating shift that overlaps with 2400h
Individuals who were high risk for sleep apnea on the Berlin Questionnaire and are not CPAP adherent
Participants with a current psychiatric disorder who are also on medications that significantly increase the risk of seizure. The antidepressants clomipramine, bupropion, maprotiline will be excluded because they are known to increase risk of up to 0.5-2.2% from a population reference range of 0.07- 0.08% in the general population and 0.1-4% in the population of people taking antidepressants.
  • Insomnia Severity Index (ISI)Insomnia severity index will be collected within one week before and within one week after the 10 sessions (over two weeks) of rTMS therapy.

    Improvement in insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). ISI is a 7-item self-report questionnaire designed to assess the severity of insomnia symptoms and their impact on daily functioning. Each question is scored on a 5-point Likert scale, with ratings from 0 (no problem) to 4 (very severe problem).

  • Pittsburgh Sleep Quality IndexPittsburgh Sleep Quality Index will be collected within one week before and within one week after the 10 sessions (over two weeks) of rTMS therapy.

    Improvement in subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). PSQI is a widely used questionnaire that assesses sleep quality and disturbances over one month. It includes seven components and ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score above 5 is generally considered indicative of poor sleep quality.