Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656533
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Optimizing the Timing of RTMS to Enhance the Administration of Insomnia Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Insomnia Treatment by Optimizing Timing of RTMS Administration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREAT
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None