NCT06631209 · University of Arizona
Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial
What this study is about
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.
View original scientific 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.
Interventions
DEVICE
Transcranial Magnetic Stimulation (TMS)
Specifically, Continual Theta Burst Stimulation
OTHER
Sham
Sham TMS
Primary outcome measures
Sleep stage changes as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Change in scores on the Pre-Sleep Arousal Scale (PSAS)
Time frame: 4 months
Scale will be taken daily for main 4 weeks of study and taken again at 1 month and 3 month followup. Total score ranging from 16-80. Two subscores (somatic and cognitive arousal) ranging from 8-40. Higher scores indicating greater arousal
Change in Insomnia Severity Index (ISI) score
Time frame: 4 months
Scale will be taken before and after treatment and at followups at 1 month and 3 months. Score ranging from 0-28 with higher scores indicating greater levels of insomnia.
Sleep duration change as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Sleep efficiency change as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Sleep latency change as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Wakefulness after sleep onset (WASO) change as determined by Polysomnography
Time frame: 1 month
PSG will be taken nightly during at home monitoring and treatment
Change in DMN within-network connectivity during resting state
Time frame: 3 weeks
fMRI data will be collected during resting state in the scanner for pre and post
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Exclusion criteria
- 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
Where
- Tucson, Arizona
Collaborators
U.S. Army Medical Research Acquisition Activity
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2025 · Source of record for eligibility and locations