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Transcranial Magnetic Stimulation for Insomnia

This study is investigating a new approach to improve sleep for people with primary insomnia. Researchers believe that excessive activity in a specific brain network, called the Default Mode Network (DMN), might contribute to difficulty sleeping. This trial will use a device called continuous theta burst (cTBS) transcranial magnetic stimulation (TMS) to temporarily change the activity in the DMN. You would receive either the active cTBS TMS or a sham (inactive) version. The study aims to see if this treatment can improve sleep quality, brain chemistry, and how different parts of the brain connect, as well as next-day thinking skills. To join, you must be between 18 and 50 years old, healthy, and meet the criteria for primary insomnia. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This interventional study plans to enroll 20 participants. It compares active cTBS TMS to a sham cTBS TMS, meaning some participants will receive the active treatment and others a placebo-like treatment.
What's involved
You would have overnight visits on day 8 and day 15, which include pre- and post-TMS MRI scans. The study will also measure sleep parameters and cognitive performance.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured on day 8 and day 15 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04953559

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

Recruiting
NAAges 18–50InterventionalTreatment
University of Arizona
~20 participants
Updated 2022-08-17 on ClinicalTrials.gov
What's tested:Active cTBSSham cTBS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 8
Measured over Once during Overnight Visit 1 pre-TMS MRI scan session (day 8)
+15 more outcomes measured

Conditions

Insomnia, Primary

Explore related trials

Insomnia

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

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

Who to contact

William D Killgore, PhD
[email protected]
(520) 621-0605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 8Once during Overnight Visit 1 pre-TMS MRI scan session (day 8)

    Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan

  • Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 8Once during Overnight Visit 1 post-TMS MRI scan session (day 8)

    Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan

  • Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 15Once during Overnight Visit 2 pre-TMS MRI scan session (day 15)

    Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan

  • Within-subject changes in functional connectivity and brain metabolites following administration of active or sham cTBS TMS - day 15Once during Overnight 2 post-TMS MRI scan session (day 15)

    Measure neurochemistry in anterior cingulate and occipitoparietal cortex using spectroscopy during MRI scan

  • Sleep onset latency (SOL) following administration of active or sham cTBS TMS - day 8During in-lab periods while sleeping during Overnight Visit 1 (day 8-9)

    Sleep period polysomnographic (PSG) measurement

  • Sleep onset latency (SOL) following administration of active or sham cTBS TMSDuring in-lab periods while sleeping during Overnight Visit 2 (day 15-16)

    Sleep period polysomnographic (PSG) measurement day 15

  • Total sleep time (TST) following administration of active or sham cTBS TMS - day 8-9During in-lab periods while sleeping during Overnight Visit 1 (day 8-9)

    Sleep period polysomnographic (PSG) measurement

  • Total sleep time (TST) following administration of active or sham cTBS TMS - day 15-16During in-lab periods while sleeping during Overnight Visit 2 (day 15-16)

    Sleep period polysomnographic (PSG) measurement

  • Sleep efficiency (SE) following administration of active or sham cTBS TMS - day 8-9During in-lab periods while sleeping during Overnight Visit 1 (day 8-9)

    Sleep period polysomnographic (PSG) measurement

  • Sleep efficiency (SE) following administration of active or sham cTBS TMS - day 8-9During in-lab periods while sleeping during Overnight Visit 2 (day 15-16)

    Sleep period polysomnographic (PSG) measurement

  • Wake after sleep onset (WASO) following administration of active or sham cTBS TMS - day 8-9During in-lab periods while sleeping during Overnight Visit 1 (day 8-9)

    Sleep period polysomnographic (PSG) measurement

  • Wake after sleep onset (WASO) following administration of active or sham cTBS TMS - day 15-16During in-lab periods while sleeping during Overnight Visit 2 (day 15-16)

    Sleep period polysomnographic (PSG) measurement

  • Time spent in each sleep stage following administration of active or sham cTBS TMSDuring in-lab periods while sleeping during Overnight Visit 1 (day 8-9)

    Sleep period polysomnographic (PSG) measurement (time) day 8

  • Percentage of time spent in each sleep stage following administration of active or sham cTBS TMSDuring in-lab periods while sleeping during Overnight Visit 1 (day 8-9)

    Sleep period polysomnographic (PSG) measurement (percentage of time) day 8

  • Time spent in each sleep stage following administration of active or sham cTBS TMSDuring in-lab periods while sleeping during Overnight Visit 2 (day 15-16)

    Sleep period polysomnographic (PSG) measurement (time) day 15

  • Percentage of time spent in each sleep stage following administration of active or sham cTBS TMSDuring in-lab periods while sleeping during Overnight Visit 2 (day 15-16)

    Sleep period polysomnographic (PSG) measurement (percentage of time) day 15