Using brain stimulation to improve sleep in people with insomnia

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

This study is testing if a brain stimulation technique can help people with insomnia sleep better by calming down a part of the brain that may be overactive.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Arizona (Academic / other)
• Locations: 1 site (Tucson, Arizona)
• Trial ID: NCT04953559 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the effects of transcranial magnetic stimulation (TMS) on the Default Mode Network (DMN) in individuals suffering from primary insomnia. The researchers hypothesize that excessive activation of the DMN contributes to difficulties in falling and staying asleep. By applying continuous theta-burst stimulation (cTBS) to the DMN before sleep, the study seeks to alter neural connectivity and improve sleep quality, brain neurochemistry, and cognitive performance the following day. Participants will be assessed using various sleep quality questionnaires to determine eligibility and outcomes.

Who should consider this trial

Good fit: Ideal candidates are healthy men and non-pregnant, non-lactating women aged 18-50 who meet the criteria for primary insomnia.

Not a fit: Patients with contraindicated medical devices or conditions that pose safety risks for TMS will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel non-pharmacological treatment for insomnia, improving sleep quality and cognitive function.

How similar studies have performed: While the approach of using TMS for insomnia is relatively novel, preliminary studies have shown promise in altering brain activity to improve sleep outcomes.

Eligibility criteria

Inclusion Criteria:

* Healthy men and non-pregnant, non-lactating women 18-50 (inclusive) years of age, free from contraindicated diseases, medications, devices, and conditions.
* 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:

  * 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)

Exclusion Criteria:

* 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
  * Artificial arms, hands, legs, etc.
  * Brain stimulator devices
  * Implanted drug pumps
  * Ear implants
  * Eye implants or known metal fragments in eyes
  * Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)
  * Other metallic surgical hardware in vital areas
  * Certain tattoos with metallic ink
  * Certain transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop (scopolamine for motion sickness), or Ortho Evra (birth control)
* 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)
* Travel outside the time zone within the two weeks prior to enrollment visit and at any point while active in the study
* 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)
* 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)
* 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)
* Self-reported past or present history of any seizures or seizure disorders
* Self-reported first-degree family history (like a mother, father, or sibling) of a seizure or seizure disorder
* Self-reported underlying acute or chronic pulmonary disease requiring daily inhaler use
* Self-reported history of fainting spells or syncope
* 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)
* Self-reported history of depression and/or anxiety disorders within the past 2 years
* Self-reported suicidal ideation as indicated by a score equal to or greater than 2 on the BDI
* 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.
* Self-reported current use of supplements that may affect sleep (to include but not limited to melatonin, valerian root, kava root)
* 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
* Self-reported or suspected regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week within the last 1 year)
* Self-reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week)
* Self-reported or suspected use of illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, opioids)
* (Females only) Positive urine pregnancy result (Urine HCG Test results)
* (Females only) Self-reported or suspected current breast-feeding or collecting breast-milk
* Learned English past age 3
* Speaking English as a non-primary language
* Less than 9th grade education
* Unusual sleep schedules in past six months
* Overnight shift work
* Inability to read and sign consent
* Failure to cooperate with requirements of the study

Where this trial is running

Tucson, Arizona

• University of Arizona Psychiatry Department — Tucson, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: William D Killgore, PhD — University of Arizona
• Study coordinator: William D Killgore, PhD

Conditions Insomnia, Primary