Transcranial Magnetic Stimulation for Insomnia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Transcranial Magnetic Stimulation (TMS) to determine its effectiveness in improving sleep for people with insomnia. Participants will receive TMS targeted at different brain areas over a two-to-three week period to assess its long-term impact on sleep, up to three months. The study includes four groups: three will receive active TMS targeting different brain areas, and one will receive a sham (inactive) treatment. Suitable candidates for this trial are those diagnosed with insomnia who experience moderate to severe sleep issues. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new sleep treatments.
Will I have to stop taking my current medications?
The trial requires that participants do not use certain prescription medications that can influence seizure threshold or neuroimaging findings. If you are taking such medications, you may need to stop them to participate.
What prior data suggests that Transcranial Magnetic Stimulation is safe for treating insomnia?
Studies have shown that Transcranial Magnetic Stimulation (TMS) is generally safe. TMS uses magnetic fields to stimulate the brain and has mostly been used to treat depression. Researchers are also exploring its use for other conditions, such as insomnia.
Research indicates that TMS is well-tolerated, with most people experiencing only mild side effects like headaches or scalp discomfort, which usually resolve on their own. Theta burst stimulation (TBS), a specific type of TMS used in this study, is also considered safe. However, due to its novelty, doctors recommend using it with caution.
Overall, TMS is a non-invasive and straightforward procedure. Following all safety guidelines during treatment is important to ensure the best possible experience for participants.12345Why are researchers excited about this trial?
Researchers are excited about transcranial magnetic stimulation (TMS) for insomnia because it offers a non-invasive approach that directly targets specific brain areas involved in sleep regulation. Unlike traditional insomnia treatments such as cognitive-behavioral therapy or medications like benzodiazepines and non-benzodiazepine hypnotics, TMS uses magnetic fields to stimulate neurons without the need for drugs. This technique targets areas like the Posterior Cingulate Cortex, Inferior Parietal Lobule, and Dorsomedial Prefrontal Cortex, potentially reducing side effects commonly associated with medication. Additionally, the precise targeting of brain regions could lead to quicker and more effective results, offering new hope for those struggling with sleep disorders.
What evidence suggests that this trial's treatments could be effective for insomnia?
This trial will compare different active stimulation targets of transcranial magnetic stimulation (TMS) for treating insomnia, including the Posterior Cingulate Cortex, Inferior Parietal Lobule, and Dorsomedial Prefrontal Cortex, along with a sham stimulation group. Studies have shown that TMS can help people with insomnia sleep better. One study found that individuals who received TMS treatment were less likely to experience a return of insomnia within three months compared to those who did not receive the treatment. Additionally, a review of several studies demonstrated that TMS could effectively help with insomnia, especially when depression is also present. While some research highlights limitations, the overall findings suggest that TMS could be a promising treatment for improving sleep in people with insomnia.678910
Are You a Good Fit for This Trial?
This trial is for individuals suffering from insomnia. Participants must pass an initial screening, including a psychological interview and at-home sleep monitoring. They should be willing to undergo physical exams, wear sleep monitors nightly, and attend 10 lab visits over two-to-three weeks for treatment sessions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Intervention Monitoring
Participants undergo a week-long at-home monitoring phase with sleep and brain wave monitors
Treatment
Participants receive 10 sessions of cTBS or sham stimulation over 2-3 weeks, with cognitive testing and brain scanning
Post-Intervention Monitoring
Participants continue at-home monitoring for 7 nights and complete a final close-out visit
Follow-up
Participants complete online assessments and a psychological interview at 1-month and 3-months post-study
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Migraine Headache Symptoms
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
U.S. Army Medical Research Acquisition Activity
Collaborator