Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep
ConditionInsomnia, Primary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Arizona
About this trial
Insomnia is generally believed to be caused by excessive arousal of the brain and body. Rather than transitioning normally and quickly from wakefulness to sleep, individuals with insomnia tend to enter into a self-perpetuating cycle of self-referential thought and arousal. Brain imaging research has shown that these same internally focused self-reflective thoughts tend to activate a core system in the brain known as the Default Mode Network (DMN). The DMN is usually active when a person is internally focused, such as during daydreaming or mind wandering, but tends to be deactivated when the brain is focused on the external environment. The investigators hypothesize that excess activation and connectivity of this brain network may perpetuate internal conversations, worry, and rumination, preventing individuals with insomnia from falling asleep quickly and remaining asleep. Therefore, the goal of the present study is to use a brain stimulation technique known as transcranial magnetic stimulation (TMS) to target the DMN and slightly reduce its activation before bed. This should result in an easier time falling asleep.
For this study, the investigators will recruit 20 healthy individuals and have them sleep in the lab on two occasions. On one occasion, they will be stimulated with a type of TMS called continuous theta burst stimulation (cTBS), which will be targeted toward their DMN. They will then try to sleep in the lab while the investigators record their brain waves using a technique known as polysomnography (PSG). On the other occasion, these same individuals will undergo the same procedure, but the TMS machine will be in a deactivated mode to present a "sham" stimulation. Participants will again try to sleep in the lab following the sham treatment while being recorded with PSG. Neither the participants nor the experimenters will know which condition the participant is receiving at the time. This will only be revealed later. Additionally, all participants will receive a brain scan just before and just after the TMS procedures so that the investigators can examine changes in brain connectivity and chemistry. The investigators expect that the participants will sleep better following the cTBS than following the sham condition and that this will be associated with measurable differences in their brain connectivity and brain chemistry.
If effective, this project would have identified an innovative and novel approach for improving sleep without using drugs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy men and non-pregnant, non-lactating women 18-50 (inclusive) years of age, free from contraindicated diseases, medications, devices, and conditions.
Greater than or equal to 15 for ISI (Gagnon, Belanger, Ivers, & Morin, 2013)
Greater than or equal to 6 for PSQI (Buysse et al 1989)
Greater than or equal to 11 for ESS (Johns, 2000)
Disqualifiers
Presence of any metal implant or medical device which may pose a safety risk for MRI or TMS (see below for examples)
Cardiac pacemakers
Metal clips on blood vessels (also called stents)
Artificial heart valves
Trial design
Design model
Crossover
Treatments tested in this trial
Active cTBS
DeviceActive continuous theta burst (cTBS) transcranial magnetic stimulation (TMS)
Sham cTBS
DeviceSham continuous theta burst (cTBS) transcranial magnetic stimulation (TMS)
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Active cTBS first, then sham cTBSExperimental treatment 2 interventions
Group B: Sham cTBS first, then active cTBSExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 8
Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan
Time frame
Once during Overnight Visit 1 pre-TMS MRI scan session (day 8)2
Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 8
Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan
Time frame
Once during Overnight Visit 1 post-TMS MRI scan session (day 8)3
Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 15
Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan
Time frame
Once during Overnight Visit 2 pre-TMS MRI scan session (day 15)4
Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 15
Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan
Time frame
Once during Overnight 2 post-TMS MRI scan session (day 15)Secondary outcomes
1
Karolinska Sleepiness Scale (KSS) - day 8, admin 1
To evaluate effects of sleep schedule on subjective sleepiness. Volunteers are presented with a 9-point sleepiness scale on a computer monitor (1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep) and select the number on the scale that best reflects their current level of subjective sleepiness.
Time frame
Once during cognitive testing portion of Overnight Visit 1 (day 8-9), day 82
Karolinska Sleepiness Scale (KSS) - day 8, admin 2
To evaluate effects of sleep schedule on subjective sleepiness. Volunteers are presented with a 9-point sleepiness scale on a computer monitor (1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep) and select the number on the scale that best reflects their current level of subjective sleepiness.
Time frame
Approximately one hour after previous administration during cognitive testing portion of Overnight Visit 1 (day 8-9), day 83
Karolinska Sleepiness Scale (KSS) - day 8, admin 3
To evaluate effects of sleep schedule on subjective sleepiness. Volunteers are presented with a 9-point sleepiness scale on a computer monitor (1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep) and select the number on the scale that best reflects their current level of subjective sleepiness.
Time frame
Approximately one hour after previous administration (2 hours after initial) during cognitive testing portion of Overnight Visit 1 (day 8-9), day 84
Karolinska Sleepiness Scale (KSS) - day 9, admin 4
To evaluate effects of sleep schedule on subjective sleepiness. Volunteers are presented with a 9-point sleepiness scale on a computer monitor (1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep) and select the number on the scale that best reflects their current level of subjective sleepiness.
Time frame
Once during cognitive testing portion of Overnight Visit 1 (day 8-9), day 9Sponsors and contacts
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Source ClinicalTrials.gov