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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how repetitive transcranial magnetic stimulation (rTMS) might improve sleep for individuals with insomnia. The researchers aim to determine if the timing of sessions, either in the morning or evening, affects sleep quality. Participants will have their sleep monitored throughout the trial to track changes. This trial may suit those with a diagnosed insomnia disorder who live near Stanford University and do not experience other major sleep disruptions. 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 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 prior data suggests that this technique is safe for treating insomnia?

In a previous study, researchers found that repetitive transcranial magnetic stimulation (rTMS) might safely and effectively treat insomnia. This technique uses a magnetic field to stimulate specific brain areas. Safety reports from other studies have shown that rTMS is generally well-tolerated, with no major side effects directly linked to the treatment. Although rTMS is already approved for other conditions, more research is needed to fully understand its effects on insomnia. However, it appears promising in terms of safety so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about repeated transcranial magnetic stimulation (rTMS) for insomnia because it offers a non-invasive approach that directly targets brain activity, unlike traditional treatments like medication or cognitive behavioral therapy. Most current insomnia treatments involve either altering chemical pathways with drugs or engaging in long-term therapy, but rTMS uses magnetic fields to stimulate specific brain areas, potentially providing quicker, side-effect-free relief. This technique could be particularly beneficial for those who have not found success with existing options, as it directly engages with the neural pathways associated with sleep regulation.

What evidence suggests that rTMS is effective for insomnia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can improve sleep in people with insomnia. In this trial, participants will be divided into two groups: the Morning Group and the Evening Group. Both groups will receive rTMS therapy targeting the right dorsolateral prefrontal cortex (DLPFC) over two consecutive weeks. Studies have found that rTMS improves scores on the Pittsburgh Sleep Quality Index (PSQI), which measures sleep quality, and reduces the recurrence of insomnia over time. Sleep quality significantly improved after rTMS sessions, and this improvement was linked to a decrease in depression symptoms. Additionally, rTMS is considered a safe and effective treatment for insomnia. These findings suggest that rTMS could be a promising option for enhancing sleep quality. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. 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, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725001868

The effects of transcranial magnetic stimulation on patients ... Previous studies have indicated that patient's treated with rTMS had the lowest relapse rate within 3 months compared to insomnia patients who received ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1458696/full

Effect of sleep quality on repetitive transcranial magnetic ... Results: We found that sleep quality improves after TMS (p<.001) and correlates with improvement in non-insomnia related depression symptoms (r= .318, p<.001).

4. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03751-y

Effect of combined treatment with transcranial direct current ... Both tDCS and rTMS have shown positive effects in treating insomnia, with high safety and sustained efficacy reported. While both have their ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9846

Effects of transcranial magnetic stimulation on sleep quality ... The primary outcome was a change in sleep quality after rTMS treatment, as measured by the total PSQI score. Secondary outcomes were a change in depression ...

6. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10954

Impact of deep transcranial magnetic stimulation on insomnia ... Our results suggest that dTMS holds promise to improve insomnia outcomes in patients with TRD. However, the study's limitations, including its ...

7. medrxiv.org medrxiv.org/content/10.1101/2023.12.06.23299444v1

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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06710652

Efficacy and Safety of Transcranial Magnetic Stimulation in ... The efficacy and safety of rTMS for cognitive impairment in insomnia patients with SCD will be assessed by a randomized controlled trial. Official Title.