Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT04953559

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

Led by University of Arizona ยท Updated on 2022-08-17

20

Participants Needed

1

Research Sites

55 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy men and non-pregnant, non-lactating women aged 18 to 50 years
  • Must meet primary insomnia criteria by scoring at least 15 on ISI, 6 on PSQI, or 11 on ESS questionnaires (two out of three required)
Not Eligible

You will not qualify if you...

  • Any metal implants or medical devices unsafe for MRI or TMS, including pacemakers, blood vessel clips, artificial heart valves, prosthetic limbs, brain stimulators, implanted drug pumps, ear or eye implants, shrapnel, metallic surgical hardware, certain metallic tattoos, or certain transdermal patches
  • History or presence of sleep or breathing disorders like sleep apnea (STOP-BANG score 3+)
  • Travel across time zones within 2 weeks before or during the study
  • History of major medical, cardiovascular, neurological, or seizure disorders
  • Family history of seizures or seizure disorders
  • Chronic pulmonary disease requiring daily inhalers
  • History of fainting or syncope
  • Past or present psychiatric disorders excluding depression or anxiety
  • Depression or anxiety within past 2 years
  • Suicidal ideation with BDI score 2 or higher
  • Current use of sleep-affecting prescription medications
  • Use of sleep-affecting supplements
  • Excessive caffeine intake (over 300 mg daily)
  • Regular nicotine use or addiction
  • Heavy alcohol use (14+ drinks per week)
  • Use of illicit drugs
  • Pregnancy or breastfeeding (females only)
  • Learned English after age 3 or non-primary English speakers
  • Less than 9th grade education
  • Unusual sleep schedules or overnight shift work in past 6 months
  • Inability to read, sign consent, or cooperate with the study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Arizona Psychiatry Department

Tucson, Arizona, United States, 85724

Actively Recruiting

Loading map...

Research Team

W

William D Killgore, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here