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

NCT06631209 | Recruiting FDA Device

• 1 other identifier: STUDY00005073
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Sleep Quality; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (8)

• Sleep stage changes as determined by Polysomnography

  PSG will be taken nightly during at home monitoring and treatment

  1 month

• Change in scores on the Pre-Sleep Arousal Scale (PSAS)

  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

  4 months

• Change in Insomnia Severity Index (ISI) score

  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.

  4 months

• Sleep duration change as determined by Polysomnography

  PSG will be taken nightly during at home monitoring and treatment

  1 month

• Sleep efficiency change as determined by Polysomnography

  PSG will be taken nightly during at home monitoring and treatment

  1 month

• Sleep latency change as determined by Polysomnography

  PSG will be taken nightly during at home monitoring and treatment

  1 month

• Wakefulness after sleep onset (WASO) change as determined by Polysomnography

  PSG will be taken nightly during at home monitoring and treatment

  1 month

• Change in DMN within-network connectivity during resting state

  fMRI data will be collected during resting state in the scanner for pre and post

  3 weeks

Secondary Outcomes (32)

• Change in DMN activity during a cognitively demanding task

  1 week

• Change in GABA levels in the posterior cingulate cortex

  3 weeks

• Change in glutamate/glutamine (glx) levels in the posterior cingulate cortex

  3 weeks

• Correlation between changes in GABA/glx levels and changes in resting state functional connectivity within the DMN

  3 weeks

• Correlation between changes in GABA/glx levels and changes in functional deactivation of the DMN during a cognitive challenge task

  3 weeks

Study Arms (4)

Active Stimulation - Posterior Cingulate Cortex

ACTIVE COMPARATOR

Active Stimulation targeted at the Posterior Cingulate Cortex

Device: Transcranial Magnetic Stimulation (TMS)

Active Stimulation - Inferior Parietal Lobule

ACTIVE COMPARATOR

Active Stimulation targeted at the Inferior Parietal Lobule

Device: Transcranial Magnetic Stimulation (TMS)

Active Stimulation - Dorsomedial Prefrontal Cortex

ACTIVE COMPARATOR

Active Stimulation targeted at the Dorsomedial Prefrontal Cortex

Device: Transcranial Magnetic Stimulation (TMS)

Sham Stimulation

SHAM COMPARATOR

The TMS device will be placed to the head but no energy will be emitted.

Other: Sham

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

Specifically, Continual Theta Burst Stimulation

Active Stimulation - Dorsomedial Prefrontal Cortex; Active Stimulation - Inferior Parietal Lobule; Active Stimulation - Posterior Cingulate Cortex

Sham OTHER

Sham TMS

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• U.S. Army Medical Research Acquisition Activity: collaborator

Study Sites (1)

SCAN Lab

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Transcranial Magnetic Stimulation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

William Killgore, Ph.D.

CONTACT

520-621-0605; killgore@psychiatry.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be 4 parallel groups of 30 participants, each receiving either one of the 3 possible stimulation sites or receiving placebo "Sham". The total number of subjects to be recruited locally to complete all study activities will be n=120. Due to prior experience with similar multi-day studies, it is expected that \~20% dropout before completion. Therefore, assuming this dropout rate (i.e., 24 consented participants), the plan is to enroll a total of 144 participants to achieve the final sample of 120 unable datasets.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 8, 2024
• Study Start: June 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-10

Locations

US (1)