Maintenance TMS for Depression

Overseen By Eric Tirrell, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Seizure disorder, Brain injury, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to evaluate the use of ecological-momentary-assessment (EMA) as a method for scheduling maintenance treatments for patients with Major Depressive Disorder (MDD) who responded to an initial acute course of Transcranial Magnetic Stimulation (TMS). To assess symptom re-emergence and severity over time, the Patient Health Questionnaire-9 item (PHQ-9) will be administered weekly via a prompt with a link send to a participants' smart phones. Adaptive algorithm software will monitor each participant's PHQ-9 scores over time and determine when a threshold increase in symptoms has occured and maintenance TMS sessions should be offered. Participants in this study will be randomized to either receive weekly EMA (monitoring only) or weekly EMA with maintenance TMS sessions (scheduled as indicated by the EMA algorithm). Participation for each subject will last for one year, with maintenance TMS offered as an adjunct to ongoing treatment as usual (TAU) for depression, i.e., ongoing pharmacotherapy, psychotherapy.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. It mentions that maintenance TMS is offered as an addition to your usual treatment, which includes ongoing medication and therapy for depression.

Is maintenance TMS safe for humans?

Transcranial magnetic stimulation (TMS) is generally considered safe for treating major depression, with studies showing it is well-tolerated by patients. Safety data from various studies indicate that TMS is a safe treatment option, even when used for maintenance to prevent relapse. ^{1 2 3 4 5}

How is maintenance TMS treatment different from other depression treatments?

Maintenance TMS (transcranial magnetic stimulation) is unique because it involves non-invasive brain stimulation to help prevent depression relapse after initial treatment success. Unlike daily treatments, it uses periodic sessions, often grouped in clusters, to maintain the antidepressant effects over time, reducing the risk of relapse. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Maintenance TMS for Depression?

Research shows that repetitive transcranial magnetic stimulation (TMS) applied to the prefrontal cortex can improve symptoms of major depression, and maintenance TMS may help reduce the chance of depression coming back after initial treatment. ^{4 7 10 11 12}

Who Is on the Research Team?

Linda Carpenter, MD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with Major Depressive Disorder who've had a positive response to Transcranial Magnetic Stimulation (TMS) therapy. Participants must have a PHQ-9 score under 10, access to a smartphone, and be medically cleared for TMS. It's not suitable for those who don't meet the standard criteria for clinical TMS.

Inclusion Criteria

Your PHQ-9 score is less than 10.

You still meet the regular requirements for the clinical procedure and your doctor has approved you to receive the treatments.

You need to have a smartphone and know how to use it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial TMS Treatment

Participants receive an initial acute course of TMS therapy

6 weeks

EMA Monitoring

Weekly EMA monitoring with PHQ-9 surveys to assess symptom re-emergence and severity

1 year

Weekly virtual assessments

Maintenance TMS

Cluster of 5 TMS sessions offered if PHQ-9 scores reach threshold, per algorithm

3-5 days per cluster

Follow-up

Participants are monitored for safety and effectiveness after maintenance TMS sessions

1 year

Assessments every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• EMA Monitoring
• Scheduling Maintenance TMS sessions

Trial Overview The study tests if using real-time assessments through smartphones can help schedule maintenance TMS sessions effectively. Patients will either just be monitored weekly or receive additional TMS treatments when an algorithm detects symptom worsening over one year.

How Is the Trial Designed?

Group I: EMA+Maintenance TMS Experimental Treatment 2 Interventions

Weekly EMA monitoring and a cluster of 5 maintenance sessions scheduled if/when PHQ9 scores reach threshold, per algorithm. Participants continue other concurrent treatment as usual (TAU) with medications, psychotherapy, etc per outpatient clinicians.

Group II: EMA only Active Control 1 Intervention

Weekly EMA monitoring without scheduled maintenance TMS. Participants in this arm may get TMS retreatment according to current standard of care (i.e., through their insurance coverage). Participants continue other concurrent treatment as usual (TAU) with medications, psychotherapy, etc per outpatient clinicians.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) is shown to be safe for patients with major depressive disorder, with no significant increase in dropout rates or serious adverse events compared to sham treatment, based on a meta-analysis of 53 trials involving 3,273 participants.

While TMS may lead to some mild and transient non-serious adverse events like headaches and discomfort, these side effects are manageable, suggesting that TMS can be a viable treatment option either alone or alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. Wang, WL., Wang, SY., Hung, HY., 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]

Transcranial magnetic stimulation (TMS) was effective in treating treatment-resistant depression, with a response rate of 50.6% and a remission rate of 24.7% after 6 weeks of treatment in a cohort of 100 patients.

TMS was well tolerated, showing a low discontinuation rate of 3% and no serious adverse events, indicating its safety as an adjunctive treatment for patients who have not responded to other antidepressant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. Connolly, KR., Helmer, A., Cristancho, MA., et al.[2022]

Citations

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

Repetitive transcranial magnetic stimulation of the prefrontal cortex in depression. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Maintenance transcranial magnetic stimulation reduces depression relapse: a propensity-adjusted analysis. [2018]

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

Prefrontal EEG asymmetry as a potential biomarker of antidepressant treatment response with transcranial magnetic stimulation (TMS): a case series. [2017]

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

Transcranial magnetic stimulation in the treatment of depression. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the management of mood disorders. [2022]

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

Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. [2022]

7. 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]

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

Relapse prevention (RP) TMS. [2022]

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

Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. [2022]

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

One Hundred Courses of Cluster Maintenance Transcranial Magnetic Stimulation (CM TMS)-A Clinical Audit Study. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Investigating the Role of Maintenance TMS Protocols for Major Depression: Systematic Review and Future Perspectives for Personalized Interventions. [2023]

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

Early relapse (ER) transcranial magnetic stimulation (TMS) in treatment resistant major depression. [2022]