NCT06656533

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

Improving Insomnia Treatment by Optimizing Timing of RTMS Administration

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Low frequency (1 Hz) rTMS has shown promise to reduce cortical hyperexcitability and to improve subjective measures of sleep quality and insomnia symptoms in patients with insomnia disorder (ID) (Nardone et al. 2020). However, the few studies to date that have examined the objective measures of sleep parameters using Polysomnography (PSG), have yielded heterogeneous results. The variability in the PSG measures of sleep may potentially be attributed to the effectiveness of rTMS therapy delivered at different times of day because of changes in cortical excitability related across the 24-hour period (Ly et al. 2016) as well as the temporal proximity of the stimulation to sleep. However, the impact of the timing of rTMS administration on improving insomnia has not yet been examined. In this pilot study, the investigators aim to demonstrate the feasibility of the data acquisition using the proposed protocol and to establish preliminary data that would be used in a future R-level grant. Building on this preliminary data, the future R-level grant would be focused on optimizing rTMS therapy for insomnia and sleep quality by manipulating the time of day that the rTMS sessions are delivered. In the following, the investigators will provide their aims for this pilot study. The investigators' objectives are 1. To assess the impact of morning versus evening administration of rTMS on a) subjective and b) objective sleep outcomes. Here the investigators propose to enroll 10 participants and randomize each to either receive 10 sessions of rTMS over two weeks in the morning or in the evening. This pilot study would provide preliminary time-of-day effects on subjective (sleep diary parameters and insomnia severity) and objective sleep (wristwatch actigraphy and PSG) measures. It characterizes the time course of improvement across the two-week treatment period for a) subjective and b) objective sleep measures. Throughout the multi-week intervention, the investigators will collect subjective and objective sleep measures to characterize the improvement across the two-week period. Finally, this pilot study would determine whether cortical excitability predicts treatment outcomes. Participants will undergo a TMS-EEG session before rTMS therapy. Cortical excitability will be assessed by measuring TMS-evoked EEG potentials (TEP).

Conditions

• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-10-24
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study