Sleep TMS for Depression

Overseen By Jade T Truong, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: Antidepressants

Disqualifiers: Intellectual disability, Neurological disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3 hours per session

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Sleep TMS for depression?

Research shows that repetitive transcranial magnetic stimulation (rTMS), a similar treatment, can improve sleep and mood in people with depression, although it doesn't directly affect sleep patterns. This suggests that Sleep TMS might help with depression by potentially improving sleep and mood. ^{1 2 3 4 5}

Is Sleep TMS safe for humans?

Transcranial magnetic stimulation (TMS), which includes Sleep TMS, is generally considered safe for treating depression. Studies show it is a non-invasive therapy with few serious side effects, even in older adults. ^{6 7 8 9 10}

How is the Sleep TMS treatment different from other depression treatments?

Sleep TMS is unique because it combines repetitive transcranial magnetic stimulation (rTMS) with sleep, potentially enhancing its effects on depression by targeting brain activity during sleep. This approach may improve sleep patterns and mood more effectively than traditional rTMS or sleep deprivation alone. ^{1 5 11 12 13}

What is the purpose of this trial?

The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.

Research Team

Corey J Keller, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals with Major Depressive Disorder (MDD) who have not had success with at least one antidepressant medication and are experiencing moderate-to-severe depression. Specific details on who cannot participate were not provided.

Inclusion Criteria

* Current Major Depressive Disorder (MDD) diagnosis

* Failed \>= 1 antidepressant medication

* Moderate-to-severe depression

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 sessions of Transcranial Magnetic Stimulation (TMS) with either active or sham iTBS during pre-sleep wakefulness or NREM sleep stages, while performing cognitive tasks.

3 hours per session

2 sessions

Follow-up

Participants are monitored for changes in sleep quality, treatment tolerability, and cognitive performance after each session.

3 hours after each session

Treatment Details

Interventions

• Sleep TMS

Trial Overview The study is testing the use of sleep-state transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique, to see if it can improve symptoms in people suffering from depression by enhancing brain plasticity during sleep.

Participant Groups

Group I: Sham TMS, Active TMS Experimental Treatment 1 Intervention

Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered during using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during pre-sleep wakefulness or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.

Group II: Active TMS, Sham TMS Experimental Treatment 1 Intervention

Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during pre-sleep wakefulness or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

In a study of 329 subjects with major depressive disorder undergoing 6 weeks of repetitive transcranial magnetic stimulation (rTMS), a lack of early improvement in mood after 1 week was a strong predictor of nonresponse to treatment, especially in those with severe depression.

By 2 weeks, those with very severe depression who showed no improvement in mood were all identified as nonresponders, indicating that early monitoring of mood and sleep can guide treatment adjustments for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absence of early mood improvement as a robust predictor of rTMS nonresponse in major depressive disorder. Mirman, AM., Corlier, J., Wilson, AC., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) is generally a well-tolerated treatment for depression, with mild side effects like headaches being the most common, while severe adverse effects are rare.

Special precautions are necessary for certain groups, such as adolescents, pregnant women, and individuals with metal implants, but with proper assessment and monitoring, rTMS can be safely administered to many patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. Taylor, R., Galvez, V., Loo, C.[2019]

Transcranial magnetic stimulation (TMS) is an effective and safe treatment for major depressive disorder (MDD), showing significant improvements in quality of life (QOL) and functional status in 307 outpatients after an acute treatment course.

Patients reported statistically significant enhancements in mental and physical health across various domains, indicating that TMS not only alleviates depressive symptoms but also leads to meaningful improvements in overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice. Janicak, PG., Dunner, DL., Aaronson, ST., et al.[2022]

In a study of 301 medication-free patients with treatment-resistant major depression, transcranial magnetic stimulation (TMS) significantly improved quality of life (QOL) and functional status compared to sham treatment during a 6-week trial.

The benefits of TMS were not only observed during the acute treatment phase but also sustained over a 24-week follow-up, indicating that TMS provides durable improvements in patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in quality of life with left prefrontal transcranial magnetic stimulation in patients with pharmacoresistant major depression: acute and six month outcomes. Solvason, HB., Husain, M., Fitzgerald, PB., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) is generally safe for older adults with late-life depression, with only 12.4% reporting any adverse events and serious adverse events occurring in just 1.5% of cases, based on a review of 11 studies involving 353 patients.

The most common adverse events were mild, such as headaches (6.9%) and discomfort at the stimulation site (2.7%), although some serious adverse events, including psychiatric hospitalization and increased suicidal ideation, were noted in case reports, highlighting the need for further research to ensure safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. Overvliet, GM., Jansen, RAC., van Balkom, AJLM., et al.[2021]

References

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

Localized potentiation of sleep slow-wave activity induced by prefrontal repetitive transcranial magnetic stimulation in patients with a major depressive episode. [2016]

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

Dosing transcranial magnetic stimulation in major depressive disorder: Relations between number of treatment sessions and effectiveness in a large patient registry. [2023]

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

Absence of early mood improvement as a robust predictor of rTMS nonresponse in major depressive disorder. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Left dorsolateral prefrontal transcranial magnetic stimulation (TMS): sleep factor changes during treatment in patients with pharmacoresistant major depressive disorder. [2015]

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

REM Sleep and Total Sleep Time Improvement After Routine Repetitive Transcranial Magnetic Stimulation in Active Duty Service Members With Depression. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019]

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

Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice. [2022]

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

Improvement in quality of life with left prefrontal transcranial magnetic stimulation in patients with pharmacoresistant major depression: acute and six month outcomes. [2018]

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

Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021]

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

A new application of rTMS: the sleeping brain and depression. [2004]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep deprivation in depression stabilizing antidepressant effects by repetitive transcranial magnetic stimulation. [2022]

13. England pubmed.ncbi.nlm.nih.gov

A systematic review for the antidepressant effects of sleep deprivation with repetitive transcranial magnetic stimulation. [2018]