JMIR Publications

ABSTRACT

Background:

Rumination and worry prior to sleep are thought to contribute to insomnia. Rumination and mind-wandering are associated greater connectivity within the Default Mode Network (DMN). Therefore, disrupting network activity within the DMN may reduce cognitive hyperarousal to facilitate better sleep. The aim of this trial is to establish a novel, non-invasive method for treating insomnia through disruption of the DMN with Transcranial Magnetic Stimulation (TMS).

Objective:

This study will be the first randomized controlled trial establishing the efficacy of TMS as a novel, non-pharmacological approach to treating insomnia through disruption of the DMN prior to sleep onset. Primary outcome measures will include assessing changes in DMN functional connectivity (FC) pre-stimulation and post-stimulation. Additionally, we will correlate changes in FC to polysomnographic graded sleep (PSG). Primary neuroimaging outcome measures will be tested using Independent Components Analysis (ICA), Seed-to Voxel Analyses, and Region of interest (ROI)-to-ROI Analyses. A repeated measures analysis of covariance (ANCOVA) will be used to assess effects of active and sham stimulation on sleep variables.

Methods:

Twenty participants with reported sleep disturbances will be recruited as a part of the study. In a double-blind, counterbalanced, crossover study design, participants will receive a 40 second stimulation to the left inferior parietal lobule of the DMN during two separate overnight in-residence visits. Participants are randomized to the order in which they receive the active stimulation and sham stimulation. Study participants will undergo a pre-stimulation functional magnetic resonance imaging (fMRI) scan and a post-stimulation fMRI scan prior to sleep for each overnight study visit. Sleep outcomes will be measured using clinical polysomnography (PSG).

Results:

Our study was funded in September of 2020 by the Department of Defense (W81XWH2010173). We completed enrollment of our target study population in the Fall of 2022 and are currently working on neuroimaging processing and analysis. We aim to publish the results of our study by January of 2024.

Conclusions:

The presently proposed cTBS protocol is aimed at establishing initial research outcomes of the effects of a single burst of cTBS on disrupting network connectivity of the DMN in order to improve sleep. If effective, future work could determine the most effective stimulation sites and administrations schedules to optimize this potential intervention for sleep problems. Clinical Trial: ClinicalTrials.gov Record 2007900971