Timing rTMS sessions to improve sleep in people with insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 1070 Arastradero Road
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Maryam Ahmadi, PhD
• Email: maryamahmadi529@gmail.com
• Phone: 9512313891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.