Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial

Description

The investigators propose to expand our previous work to test whether 10 repeated administrations of the cTBS procedure over a two-week period can lead to longer-term improvements in sleep, perhaps up to 3-months. For this 3-year study, 120 people with insomnia will be recruited to participate. There will be an initial screening, with the first consent form being for the screening questions, a psychological interview, and a one night at home sleep monitoring session with our equipment. If participants pass this first phase, they will reconsent for the main portion of the study. They will then undergo a physical examination, then a week-long at-home monitoring phase where they will wear a wristwatch sleep monitor as well as wear a portable brain wave monitor to bed each night to record sleep. Participants will continue to use this equipment throughout the treatment phase and for one week post treatment. After the first monitoring phase, each participant will be randomly assigned to one of four different conditions (i.e., 30 assigned to each group). Three of the conditions will involve cTBS focused on different brain locations (i.e., stimulation to the middle front, middle back, or side of the skull), while the fourth condition will provide inactive sham stimulation as a control. All participants will complete 10 treatment visits to the lab over two-to-three weeks, during which they will get a brief cTBS or sham stimulation each time. In addition, all participants will complete a brain scanning and cognitive testing session at the beginning and end of the two-to-three week treatment period. Participants will also complete 1-month and 3-month online follow-up assessments to examine long-term effects.

Conditions

Insomnia

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Study Overview

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Study Details

Study overview

The investigators propose to expand our previous work to test whether 10 repeated administrations of the cTBS procedure over a two-week period can lead to longer-term improvements in sleep, perhaps up to 3-months. For this 3-year study, 120 people with insomnia will be recruited to participate. There will be an initial screening, with the first consent form being for the screening questions, a psychological interview, and a one night at home sleep monitoring session with our equipment. If participants pass this first phase, they will reconsent for the main portion of the study. They will then undergo a physical examination, then a week-long at-home monitoring phase where they will wear a wristwatch sleep monitor as well as wear a portable brain wave monitor to bed each night to record sleep. Participants will continue to use this equipment throughout the treatment phase and for one week post treatment. After the first monitoring phase, each participant will be randomly assigned to one of four different conditions (i.e., 30 assigned to each group). Three of the conditions will involve cTBS focused on different brain locations (i.e., stimulation to the middle front, middle back, or side of the skull), while the fourth condition will provide inactive sham stimulation as a control. All participants will complete 10 treatment visits to the lab over two-to-three weeks, during which they will get a brief cTBS or sham stimulation each time. In addition, all participants will complete a brain scanning and cognitive testing session at the beginning and end of the two-to-three week treatment period. Participants will also complete 1-month and 3-month online follow-up assessments to examine long-term effects.

Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial

Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Tucson

SCAN Lab, Tucson, Arizona, United States, 85724

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Healthy men and non-pregnant women 18-60 (inclusive) years of age free from contraindicated diseases, medications, devices, and conditions.
  • * Must score in the moderate or higher range on the Insomnia Severity Index (ISI ≥ 15)
  • * Must meet the criteria for DSM-5 insomnia disorder as determined by a clinical interview with a board-certified sleep medicine physician.
  • * Sex ratio will be set to \~50% males; \~50% females
  • * Ethnicity ratio will be set to \~29.5% who identify as a minority; \~70.5% who identify as white
  • * Presence of any metal implant or medical device that may pose a safety risk for MRI or TMS (permanent hearing aids, cochlear implants, medication infusion devices, brain stimulation devices, permanent retainer, etc.)
  • * Self-reported past or present medical diagnosis of sleep or breathing-related disorders such as sleep apnea other than insomnia (potential confounder);
  • * Confounder of Obstructive Sleep Apnea as measured by WatchPAT device at home
  • * Travel outside the time zone within the one week prior to the physical visit and at any point while active in the study (known to affect sleep);
  • * Regular shiftwork within 6-months prior to enrollment in the study (known to affect sleep);
  • * Self-reported past or present history of any seizures or seizure disorders or other contraindication to neurostimulation, for self or any first-degree relatives (safety concern);
  • * Self-reported current use of certain prescription medications that can either influence seizure threshold, or neuroimaging findings (safety concern and potential confounder);
  • * Self-reported caffeine use in excess of 300 mg (e.g., approximately 8 caffeinated sodas or approximately 3-4 12-oz cups of coffee) per day on average (known to affect sleep; potential confounder);
  • * Self-reported or suspected substance abuse or dependence (safety concern; potential confounder);
  • * (Females only) Positive urine pregnancy result (Urine HCG Test results) (safety concern);
  • * Inability to read and sign the consent form (regulatory/ethical issue)
  • * Self-reported history of repeated, recent, or severe fainting spell or syncope
  • * Prior spinal cord surgeries or any spinal/ventricular derivations
  • * Self-reported negative experience due to neurostimulation before
  • * Deviation from self-reported normal bedtime sleep schedules (bedtime between 9:00 pm and 1:00 am

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Arizona,

Study Record Dates

2027-08