Taking people in United StatesNo phase

Testing morning versus evening magnetic brain stimulation for insomnia

Tests whether the time of day of magnetic brain stimulation matters in adults with insomnia.

Key facts

Who runs it: Stanford University
Where: Palo Alto, United StatesSee the site
Trial code: NCT06656533
Registry title: Optimizing the Timing of rTMS to Enhance the Administration of Insomnia Treatment
Status: Recruiting
People taking part: 10 people, planned
Started: 1 Mar 2025
Planned end: 30 Sept 2026
Type of study: Interventional, 2 groups
Treatments tested: Repeated Transcranial magnetic stimulation (rTMS)
Record updated: 23 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 25 to 45 with insomnia disorder. They will get 10 sessions of rTMS, a magnetic brain stimulation, in the morning or evening.

Age: 25 to 45 years (inclusive)
Sex: Males and females
Disease stage: Insomnia diagnosed with the DUKE structured interview for sleep disorders.
Earlier treatment: People who had cognitive behavioral therapy for insomnia within the past year cannot join.

Main reasons for not taking part

Other sleep or body-clock disorders that add a lot to the sleep problem, or high risk of sleep apnea without regular CPAP use
Regular use of benzodiazepine, opiate, thyroid, anticonvulsant or antipsychotic medicines, illicit drugs, substance abuse, or more than 14 drinks per week or more than 4 drinks per occasion
Neurological or heart disorders, seizures or epilepsy, stroke, brain surgery or tumor, diabetes, thyroid disease, or serious head injury
Bipolar disorder, PTSD, psychosis, current depression, or suicidal thoughts (score above 0 on BDI question #9)
Pregnancy or breastfeeding, or working a rotating shift that overlaps with 2400h

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

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

Who cannot take part

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
Received cognitive behavioral therapy for insomnia within the past year
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
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
History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities OR traumatic brain injury in the past two months
Current or lifetime history of bipolar disorder, PTSD or psychosis or current depression
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
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)
Substance abuse or dependence
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 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 25 and 45 years old?

Where in United States

1070 Arastradero RoadPalo Alto, United StatesContact: Maryam Ahmadi, PhDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

MORNING GROUPTreatment being tested
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.
Treatment: Repeated Transcranial magnetic stimulation (rTMS)
EVENING GROUPTreatment being tested
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.
Treatment: Repeated Transcranial magnetic stimulation (rTMS)