rTMS for Insomnia

(TREAT Trial)

Overseen By Andrea Goldstein Piekarski, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Benzodiazepines, Opiates, Antipsychotics, others

Disqualifiers: Neurological, Cardiovascular, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 2 weeks

10 Participants Needed

Trial Summary

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

You may need to stop certain medications, especially if you are using benzodiazepines, opiates, thyroid, anticonvulsant, or antipsychotic medications, as well as psychotropic medications that affect sleep and alertness. The trial excludes participants using these medications.

What data supports the effectiveness of the treatment Repeated Transcranial Magnetic Stimulation (rTMS) for insomnia?

Research suggests that low-frequency rTMS can improve sleep quality in people with insomnia by decreasing brain activity and improving brain connectivity. However, the effectiveness can vary between individuals, and more research is needed to predict who will benefit most from this treatment. ^{1 2 3 4 5}

Is rTMS safe for treating insomnia?

Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for treating insomnia, as suggested by research studies. It has been used for other conditions like depression, and while its effectiveness for insomnia varies, safety concerns are minimal. ^{3 4 5 6 7}

How is the treatment rTMS unique for insomnia?

rTMS (repetitive transcranial magnetic stimulation) is unique for treating insomnia because it uses magnetic fields to stimulate specific areas of the brain, potentially improving sleep quality by decreasing brain activity and remodeling brain connectivity, unlike traditional medications that often target chemical imbalances. ^{1 2 3 4 5}

What is the purpose of this trial?

Repetitive transcranial magnetic stimulation (rTMS) has shown to be a promising technique for improving insomnia symptoms and sleep quality. However, the impact of circadian rhythmicity on rTMS sessions and its potential influence on insomnia therapy remains unclear. Moreover, the effect of rTMS on objective sleep parameters is not fully established. The objective of this pilot study is to establish key feasibility and preliminary data that would be used for an R-level grant application focused on optimizing rTMS therapy for insomnia. The investigators will acquire feasibility data from ten adults with Insomnia disorder. Participants will receive ten sessions rTMS over two weeks, either in the morning or evening. Sleep parameters will be assessed before, during, and after completion of rTMS and brain cortical excitability will be collected before rTMS treatment. The investigators aim to 1) evaluate the impact of circadian timing of rTMS sessions on subjective and objective sleep outcomes, 2) assess the time course of improvements in sleep outcomes, and 3) examine the association between sleep outcomes and cortical excitability. The overarching goal of this work is to optimize rTMS therapy for insomnia by investigating the impact of circadian timing on rTMS sessions and assessing potential variations in subjective and objective measures of sleep.

Eligibility Criteria

This trial is for adults with Insomnia disorder. It aims to gather preliminary data on how well rTMS, a non-invasive brain stimulation technique, can improve sleep quality when given at different times of the day.

Inclusion Criteria

Fluent and literate in English

Written, informed consent

Reside within 60 miles of Stanford University

Exclusion Criteria

Presence of other sleep or circadian rhythm disorders that significantly contribute to their sleep disturbance. The presence of these disorders will be assessed by the DUKE structured interview for sleep disorders.

Individuals who were high risk for sleep apnea on the Berlin Questionnaire and are not CPAP adherent

Excessive alcohol consumption (>14 drinks per week or > 4 drinks per occasion)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo TMS-EEG session to assess cortical excitability before rTMS therapy

1 session

1 visit (in-person)

Treatment

Participants receive 10 sessions of rTMS therapy over two weeks, either in the morning or evening

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in sleep quality and insomnia severity after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Repeated Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests if the timing of rTMS sessions (morning or evening) affects sleep improvement in insomnia patients. Participants will undergo ten rTMS treatments over two weeks and have their sleep and brain activity measured before and after therapy.

Participant Groups

Group I: MORNING GROUP Experimental Treatment 1 Intervention

Five participants (21 to 45 years old) experiencing clinically meaningful insomnia symptoms will be enrolled and will receive 10 sessions of right dorsolateral prefrontal cortex (DLPFC) rTMS therapy in the morning over two consecutive weeks.

Group II: EVENING GROUP Experimental Treatment 1 Intervention

Five participants (21 to 45 years old) experiencing clinically meaningful insomnia symptoms will be enrolled and will receive 10 sessions of right dorsolateral prefrontal cortex (DLPFC) rTMS therapy in the evening over two consecutive weeks.

Repeated Transcranial Magnetic Stimulation (rTMS) is already approved in United States, Canada for the following indications:

Approved in United States as rTMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Chronic Pain Syndrome
• Smoking Cessation

Approved in Canada as rTMS for:

• Major Depressive Disorder (MDD)
• Chronic Pain Syndrome

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

References

1. Poland pubmed.ncbi.nlm.nih.gov

The influence of the repetitive transcranial magnetic stimulation on sleep quality in depression. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of sequential bilateral low-frequency rTMS over dorsolateral prefrontal cortex on serum level of BDNF and GABA in patients with primary insomnia. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The long-term effect of repetitive transcranial magnetic stimulation in the treatment of intractable insomnia. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Altered response to repetitive transcranial magnetic stimulation in patients with chronic primary insomnia. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Electroencephalographic connectivity predicts clinical response to repetitive transcranial magnetic stimulation in patients with insomnia disorder. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of low-frequency repetitive transcranial magnetic stimulation as adjunctive treatment for insomnia patients under hypnotics: A randomized, double-blind, sham-controlled study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

mPFC-rTMS for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial. [2022]