NCT06656533 Optimizing the Timing of rTMS to Enhance the Administration of Insomnia Treatment
| NCT ID | NCT06656533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-09-30 |
Trial Parameters
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Brief Summary
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
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
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