Timing rTMS sessions to improve sleep in people with insomnia

Improving Insomnia Treatment by Optimizing Timing of rTMS Administration

This pilot will try giving low-frequency rTMS in the morning versus the evening to see if timing changes sleep for adults with insomnia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 25 Years to 45 Years
• Sex: All
• Sponsor: Stanford University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06656533 on ClinicalTrials.gov

What this trial studies

This pilot enrolls ten adults with insomnia who will receive ten low-frequency (1 Hz) rTMS sessions over two weeks delivered either in the morning or the evening. Investigators will collect subjective sleep measures and objective sleep data including polysomnography before, during, and after the rTMS course, and will record cortical excitability before treatment. The primary aim is to demonstrate feasibility of the protocol and generate preliminary data on whether time-of-day of stimulation affects sleep outcomes. These results will inform a larger R-level grant to optimize rTMS therapy timing for insomnia.

Who should consider this trial

Good fit: Adults aged 25–45 with diagnosed insomnia disorder who live within about 60 miles of Stanford, are fluent in English, can provide informed consent, and do not take excluded psychotropic or other disallowed medications or have major neurologic, cardiovascular, or other sleep disorders are ideal candidates.

Not a fit: People with other primary sleep or circadian disorders, who use excluded medications, have significant medical or psychiatric contraindications (including suicidal ideation), or who cannot attend frequent in-person sessions are unlikely to benefit from this pilot.

Why it matters

Potential benefit: If successful, adjusting the time of day rTMS is given could lead to better sleep quality and reduced insomnia symptoms for some patients.

How similar studies have performed: Prior small studies of low-frequency rTMS have reported subjective sleep improvements but objective polysomnography results are mixed, and the effect of session timing is largely untested.

Eligibility criteria

Inclusion Criteria:

* 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 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.
* 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.

Where this trial is running

Palo Alto, California

• 1070 Arastradero Road — Palo Alto, California, United States (RECRUITING)

Study contacts

• Study coordinator: Maryam Ahmadi, PhD

Conditions: Insomnia, Sleep, rTMS Therapy