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Maintenance TMS for Depression

N/A
Recruiting
Led By Linda Carpenter, MD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with primary Major Depressive Disorder who responded (50% drop in score from pre-treatment baseline to final score on depression scale) to a standard acute course of TMS Therapy at Butler Hospital.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial evaluates using EMA to schedule maintenance TMS sessions for MDD patients who responded to initial TMS. Weekly PHQ-9 scores will be monitored and TMS sessions offered when symptoms worsen. The trial lasts one year with TMS as adjunct to usual MDD treatments.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects are not detailed here, typical TMS may include headaches, scalp discomfort during treatment, tingling or spasms of facial muscles, lightheadedness, and in rare cases seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Major Depressive Disorder and improved significantly after TMS Therapy at Butler Hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weeks in Response Range

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EMA+Maintenance TMSExperimental Treatment2 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 onlyActive Control1 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.

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
130 Previous Clinical Trials
16,463 Total Patients Enrolled
31 Trials studying Depression
6,359 Patients Enrolled for Depression
Linda Carpenter, MDPrincipal InvestigatorButler Hospital
5 Previous Clinical Trials
229 Total Patients Enrolled
2 Trials studying Depression
46 Patients Enrolled for Depression
~15 spots leftby Sep 2025