Accelerated rTMS for Insomnia

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Overseen ByJunyi Sun, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: San Francisco Neurology and Sleep Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether repetitive transcranial magnetic stimulation (rTMS) can help people with chronic insomnia sleep better. rTMS uses magnetic pulses to non-invasively stimulate specific brain areas involved in wakefulness. Participants will undergo six rTMS sessions over two weeks. The study seeks adults who have struggled with insomnia for at least three months, experiencing issues such as difficulty falling asleep, staying asleep, or waking up too early. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance insomnia treatments.

Do I need to stop my current medications for the trial?

The trial does not require you to stop your current medications, but you must be on a stable dose for at least 2 months before joining. You cannot use sleeping medications more than 4 times a week, except for certain over-the-counter options like Valerian and St. John's Wort.

What prior data suggests that this rTMS treatment is safe for insomnia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for treating insomnia. Studies have found that rTMS can significantly improve sleep quality, with only a few minor side effects reported. Serious side effects are rare and can usually be avoided with proper safety measures.

Additionally, rTMS is already used for other conditions, which supports its safety. This treatment is non-invasive and uses magnetic pulses to stimulate specific areas of the brain. It has shown promise in improving sleep without the complications that often accompany medication.

Overall, rTMS appears to be well-tolerated, making it a potential option for those looking to safely improve their sleep quality.12345

Why are researchers excited about this trial?

Most treatments for insomnia involve medications like sleeping pills or cognitive behavioral therapy, which can take time to work and may have side effects. But repetitive Transcranial Magnetic Stimulation (rTMS) offers a different approach by using magnetic pulses to stimulate brain activity. This method targets the left dorsolateral prefrontal cortex, an area linked to sleep regulation, and can potentially improve sleep patterns quickly, often within just a few sessions. Researchers are excited about rTMS because it's non-invasive, personalized to each person's brain activity, and could offer a faster, side-effect-free alternative for those struggling with insomnia.

What evidence suggests that rTMS is effective for chronic insomnia?

Research has shown that Repetitive Transcranial Magnetic Stimulation (rTMS) may improve sleep for people with insomnia. Studies have found that recipients of rTMS slept better than those who did not. Specifically, one study demonstrated that rTMS helped individuals fall asleep faster, sleep longer, and sleep more efficiently. In this trial, participants will receive rTMS treatment using the EXOMIND™ device, which delivers magnetic pulses to target a specific part of the brain involved in sleep. Overall, rTMS offers a non-invasive option that might benefit those with chronic insomnia.12467

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with chronic insomnia who have trouble falling or staying asleep at least 3 nights a week for over 3 months, and whose sleep problems cause significant distress. People can't join if they have certain medical conditions, metal implants in the head, untreated sleep apnea, serious psychiatric disorders, or are pregnant/breastfeeding.

Inclusion Criteria

* Subject must have an ISI total score ≥15 at screening.
* Subject must have an sSOL ≥45 minutes and an sWASO ≥60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the CSD-M, prior to screening Somfit™ sleep test assessments.
* Subject must demonstrate a 2-night mean SOL of ≥25 minutes (with neither night \<20 minutes), a 2-night mean WASO ≥30 minutes, and a 2-night mean TST ≤6.5 hours, with neither night \>7 hours.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 25 days
Multiple visits for assessments and at-home sleep monitoring

Open-Label Treatment

Participants receive 6 rTMS sessions over 2 weeks using the EXOMIND™ device

2 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 visits (1 month and 3 months post-treatment)

What Are the Treatments Tested in This Trial?

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The study tests whether accelerated repetitive transcranial magnetic stimulation (rTMS), using the EXOMIND device applied to the scalp six times over two weeks, can improve sleep in people with chronic insomnia. All participants receive rTMS; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: rTMS TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Francisco Neurology and Sleep Center

Lead Sponsor

Citations

Effectiveness of repetitive transcranial magnetic stimulation for ...

Meta-analyses have also shown that rTMS has good efficacy and safety in the treatment of insomnia, whether as a monotherapy or combination ...

Efficacy of Repetitive transcranial magnetic stimulation for ...

The rTMS group demonstrated markedly improved sleep quality compared with sham rTMS recipients in individuals with insomnia disorder. (PSQI ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32830052/

The effect of repetitive transcranial magnetic stimulation for ...

Compared with other treatment, rTMS was associated with improved Pittsburgh sleep quality index (PSQI) total score (SMD -0.63, 95% CI -1.22 to -0.04; Z = 2.08, ...

Efficacy and placebo response of repetitive transcranial ...

In sum, rTMS significantly improved insomnia symptoms in the active rTMS group, and the pooled effect size of Pittsburgh Sleep Quality Index (PSQI) was −0.98 ( ...

Effect of low-frequency repetitive transcranial magnetic...

After 10 sessions of low-frequency DMPFC-rTMS, the experimental group demonstrated a reduction of duration of wake after sleep onset (WASO) from 75.4 (±53.3) to ...

The effects of transcranial magnetic stimulation on patients ...

Repetitive transcranial magnetic stimulation noninvasively modulates brain synaptic plasticity, showing therapeutic potential for insomnia.

Effect of Insomnia on Repetitive Transcranial Magnetic ...

Our results suggest that while baseline insomnia is not associated with response to TMS treatment, treating insomnia may affect the trajectory of TMS therapy.