RECRUITING

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

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Conditions

Insomnia, Primary

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

Quick Facts

Study Start:2021-08-06
Study Completion:2022-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04953559

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy men and non-pregnant, non-lactating women 18-50 (inclusive) years of age, free from contraindicated diseases, medications, devices, and conditions.
  2. * Participants must meet the criteria for primary insomnia as determined by scores on the ISI, PSQI, and ESS. Participants must obtain two out of three of the following required scores for each questionnaire:
  3. * Greater than or equal to 15 for ISI (Gagnon, Belanger, Ivers, \& Morin, 2013)
  4. * Greater than or equal to 6 for PSQI (Buysse et al 1989)
  5. * Greater than or equal to 11 for ESS (Johns, 2000)
  1. * Presence of any metal implant or medical device which may pose a safety risk for MRI or TMS (see below for examples)
  2. * Cardiac pacemakers
  3. * Metal clips on blood vessels (also called stents)
  4. * Artificial heart valves
  5. * Artificial arms, hands, legs, etc.
  6. * Brain stimulator devices
  7. * Implanted drug pumps
  8. * Ear implants
  9. * Eye implants or known metal fragments in eyes
  10. * Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)
  11. * Other metallic surgical hardware in vital areas
  12. * Certain tattoos with metallic ink
  13. * Certain transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop (scopolamine for motion sickness), or Ortho Evra (birth control)
  14. * Past or present history of sleep or breathing-related disorders such as sleep apnea (exclusion upon obtaining a score of 3 or higher on the STOP-BANG questionnaire)
  15. * Travel outside the time zone within the two weeks prior to enrollment visit and at any point while active in the study
  16. * Self-reported major medical problems including past or present history of heart problems and/or neurological problems (to include but not limited to heart murmur, heart attack, TBI, stroke, tumor, epilepsy or another seizure disorder)
  17. * Self-reported past or present history of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction)
  18. * Self-reported past or present history of neurological disorder (to include but not limited to traumatic brain injury including concussions, strokes, tumors, epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, multiple sclerosis)
  19. * Self-reported past or present history of any seizures or seizure disorders
  20. * Self-reported first-degree family history (like a mother, father, or sibling) of a seizure or seizure disorder
  21. * Self-reported underlying acute or chronic pulmonary disease requiring daily inhaler use
  22. * Self-reported history of fainting spells or syncope
  23. * Self-reported past (at any point in the participant's history) or present psychiatric problems not including depression and/or anxiety disorders (to include but not limited to bipolar, mania, ADHD, or psychotic disorders)
  24. * Self-reported history of depression and/or anxiety disorders within the past 2 years
  25. * Self-reported suicidal ideation as indicated by a score equal to or greater than 2 on the BDI
  26. * Self-reported current use of certain prescription medications including Ambien, benzodiazepines, stimulants (amphetamines, medication for narcolepsy), antidepressants (SSRIs, SNRIs), antipsychotics, blood pressure medications, thyroid medications.
  27. * Self-reported current use of supplements that may affect sleep (to include but not limited to melatonin, valerian root, kava root)
  28. * 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
  29. * Self-reported or suspected regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week within the last 1 year)
  30. * Self-reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week)
  31. * Self-reported or suspected use of illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, opioids)
  32. * (Females only) Positive urine pregnancy result (Urine HCG Test results)
  33. * (Females only) Self-reported or suspected current breast-feeding or collecting breast-milk
  34. * Learned English past age 3
  35. * Speaking English as a non-primary language
  36. * Less than 9th grade education
  37. * Unusual sleep schedules in past six months
  38. * Overnight shift work
  39. * Inability to read and sign consent
  40. * Failure to cooperate with requirements of the study

Contacts and Locations

Study Contact

William D Killgore, PhD
CONTACT
(520) 621-0605
killgore@psychiatry.arizona.edu

Principal Investigator

William D Killgore, PhD
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

University of Arizona Psychiatry Department
Tucson, Arizona, 85724
United States

Collaborators and Investigators

Sponsor: University of Arizona

  • William D Killgore, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-06
Study Completion Date2022-08-31

Study Record Updates

Study Start Date2021-08-06
Study Completion Date2022-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Insomnia, Primary