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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new schedule for maintenance treatments in individuals with Major Depressive Disorder (MDD) who have improved after a series of Transcranial Magnetic Stimulation (TMS) sessions. The study uses a weekly smartphone survey to monitor mood changes and determine when additional TMS sessions are necessary. Participants are divided into two groups: one receives the survey plus TMS as needed, while the other receives only the survey. This trial suits individuals who have benefited from TMS and can regularly use a smartphone. As an unphased trial, it offers participants a unique opportunity to contribute to innovative treatment strategies for MDD.

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.

What prior data suggests that this method is safe for scheduling maintenance TMS for depression?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally safe and well-tolerated for treating depression. Studies have found that TMS is effective in both short-term and long-term use and usually does not cause serious side effects. One study reported that TMS reduced suicidal thoughts after the initial treatment period. Another study found that TMS helped prevent depression from returning in most patients over 24 weeks.

These findings suggest that ongoing TMS treatments are relatively safe for those who responded well to the initial sessions. However, some research indicates that safety and effectiveness can vary among different people. Overall, TMS is considered a safe option for many patients with depression, especially when used alongside other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing depression with maintenance Transcranial Magnetic Stimulation (TMS) combined with Ecological Momentary Assessment (EMA) monitoring. Unlike standard depression treatments that often focus solely on medication or psychotherapy, this method uses regular EMA monitoring to track symptoms in real-time. Based on these assessments, TMS sessions are strategically scheduled only when needed, potentially making treatment more personalized and efficient. This approach could lead to more timely interventions and reduce the burden of unnecessary treatments, offering a fresh perspective on managing depression more effectively.

What evidence suggests that this trial's treatments could be effective for Major Depressive Disorder?

Research has shown that Transcranial Magnetic Stimulation (TMS) effectively treats major depressive disorder (MDD). One study found that patients who continued regular TMS sessions had an 85% success rate in preventing relapse over 24 weeks. Another study demonstrated that ongoing TMS significantly reduced depression symptoms and suicidal thoughts after the initial treatment. Additionally, the rates of improvement and complete recovery with TMS were 41.2% and 35.3%, respectively. In this trial, one group of participants will receive EMA monitoring with scheduled maintenance TMS sessions, while another group will receive EMA monitoring only. These findings suggest that regular TMS can be a helpful long-term option for managing depression symptoms. ^{1 2 6 7 8}

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

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7675193/

Maintenance treatment of transcranial magnetic stimulation ... After acute TMS therapy for six weeks without adjustment for depression severity, the predictive rate of suicidal ideation was significantly reduced in ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835319

Repetitive Transcranial Magnetic Stimulation as ... The relapse prevention success rate at 24 weeks in the rTMS monotherapy group was approximately 85%, whereas prior literature indicates that the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032720325933

Clinical outcomes in a large registry of patients with major ... Randomized clinical trials have demonstrated that Transcranial Magnetic Stimulation (TMS) is an effective treatment for episodes of major depressive disorder ( ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05545-1

Short-term and long-term efficacy of accelerated transcranial ... Compared with standard TMS, aTMS can rapidly improve depressive symptoms, but there is no significant difference in efficacy. aTMS may also have ...

5. psychiatrist.com psychiatrist.com/jcp/effectiveness-transcranial-magnetic-stimulation-clinical/

Effectiveness of Transcranial Magnetic Stimulation in ... The HDRS response and remission rates were 41.2% and 35.3%, respectively. Forty-two patients (49%) entered 6 months of maintenance TMS treatment. Sixty-two ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0272735822001210

Efficacy and safety of transcranial magnetic stimulation for ... Our results suggest the effects and safety of TMS in treating MDD are likely lower in some populations than previous estimates suggested. •. Future research ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04076644?term=TMS,%20depression&viewType=Table&rank=1

Maintenance Transcranial Magnetic Stimulation in Major ... This an open label study using Transcranial Magnetic Stimulation (TMS) as a maintenance treatment for subjects that have seen a clinically significant response ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22579164/

Effectiveness of transcranial magnetic stimulation in clinical ... Conclusions: Adjunctive TMS was found to be safe and effective in both acute and maintenance treatment of patients with treatment-resistant depression.