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NCT06656533

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Official title: Improving Insomnia Treatment by Optimizing Timing of RTMS Administration

Key Details

Gender

All

Age Range

25 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-01-15

Completion Date

2025-07-31

Last Updated

2024-10-24

Healthy Volunteers

Conditions

Insomnia

Interventions

OTHER

Repeated Transcranial magnetic stimulation (rTMS)

Transcranial Magnetic Stimulation (TMS) involves a procedure where parts of the participants brain will be non-invasively (i.e. indirectly) stimulated by magnetic pulses. These magnetic pulses induce very brief activity in brain areas underlying the TMS coil. TMS will be performed by giving repetitive pulses (rTMS). rTMS has shown promise to reduce cortical hyperexcitability and to improve subjective measures of sleep quality and insomnia symptoms in patients with insomnia disorder. The goal of this study is to optimize the impact of rTMS therapy on sleep outcomes for patients with insomnia disorder.

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.

Locations (1)

1070 Arastradero Road

Palo Alto, California, United States