Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder

Conditions

• Chronic Insomnia
• Chronic Insomnia Disorder
• Insomnia
• Sleep Disturbance

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• TMS — DEVICE
  The EXOMIND™ (BTL-699-2) is a repetitive transcranial magnetic stimulation (rTMS) device that delivers targeted electromagnetic pulses to cortical brain regions. In this study, stimulation is applied to the left dorsolateral prefrontal cortex (DLPFC), a region implicated in executive function, working memory, and attention. The DLPFC target is localized using the standard 5-cm rule, measured anterior to the motor cortex hot spot. Each treatment session uses a multi-frequency protocol alternating between 12, 15, and 18 Hz stimulation frequencies, delivering a total of 6,300 pulses over 24 minutes and 30 seconds. Stimulation intensity is calibrated to each participant's resting motor threshold, defined as the minimum stimulus intensity required to produce a visible contraction of the right abductor pollicis brevis muscle. Six sessions are administered twice weekly over approximately 3 weeks.

Study Details

Chronic insomnia disorder is a common condition in which people have ongoing difficulty falling asleep, staying asleep, or waking too early. It affects about 10-12% of adults and can lead to daytime problems, stress, and other health issues. Current treatments include talk therapy (cognitive behavioral therapy for insomnia) and sleep medications, but medications can have side effects and may not work well over the long term. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses applied to the scalp to stimulate specific areas of the brain. It has shown promise in improving sleep quality in people with insomnia by targeting a brain region called the left dorsolateral prefrontal cortex, which plays a role in the overactive brain arousal thought to cause insomnia. The purpose of this study is to find out whether an accelerated course of rTMS using the EXOMIND™ device can improve sleep in adults with chronic insomnia disorder. The study will enroll approximately 70 participants aged 18 to 85 years at a single site in San Francisco. Participants will receive 6 rTMS sessions (3 times per week for 2 weeks). Each session lasts about 25 minutes. The study has three phases: a screening phase (up to 25 days) to confirm eligibility using sleep questionnaires and at-home sleep monitoring, a 2-week open-label treatment phase, and a follow-up phase with visits at 1 month and 3 months after the last treatment session. Total participation lasts up to approximately 139 days. The main goal is to measure whether insomnia severity improves after treatment, using a standard questionnaire called the Insomnia Severity Index (ISI). The study will also measure changes in objective sleep patterns (such as how long it takes to fall asleep, time spent in deep sleep, and total sleep time) recorded by a home sleep monitoring device, as well as changes in sleep quality, stress levels, and overall clinical impression of improvement. This is an open-label pilot study, meaning all participants will receive the rTMS treatment and there is no placebo group. The study does not involve any medications. Participants must not have certain medical conditions, electronic or metal implants in or near the head, untreated sleep apnea, or active serious psychiatric disorders. Participants who are pregnant or breastfeeding cannot take part.

Key Dates

Start date

May 20, 2026

Status verified

May 2026

Primary completion

May 19, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

70 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: rTMS Treatment
  Participants receive 6 sessions of repetitive transcranial magnetic stimulation (rTMS) using the EXOMIND™ device (BTL-699-2), administered 3 times per week over 2 weeks. Each session delivers 6,300 magnetic pulses at alternating frequencies of 12, 15, and 18 Hz to the left dorsolateral prefrontal cortex (DLPFC), localized using the standard 5.5-cm anterior method. Total session duration is 24 minutes and 30 seconds. Stimulation intensity is calibrated to each participant's individual motor threshold, defined as the minimum stimulus required to produce visible contraction of the right thumb. All sessions are conducted on-site at the research center with medical staff present. Blood pressure and heart rate are monitored before and after each session.

Primary Outcome Measure

Change From Baseline in Insomnia Severity Index (ISI) Total Score at 1-Month Follow-Up [ Time Frame: From baseline to the 1-month follow-up ]

Central Contacts

• Joy Shihui Meng, MD
  4156662536
  [email protected]
• Junyi Sun, MD, PhD
  4156662536
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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