TMS vs ECT for Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Austin Messner

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Electroconvulsive therapy (ECT) is one of the most efficacious treatments available for treatment-resistant depression (TRD). Although a maintenance ECT protocol exists, multiple barriers limit its use for long-term use. These barriers include procedure tolerability, cognitive side effects, financial burden, and unreliable social support to accompany patients for these treatments. On the other hand, a different modality of noninvasive neuromodulation called transcranial magnetic stimulation (TMS) can be performed in the outpatient setting and does not need anesthesia. The likelihood of cognitive adverse effects with TMS is much lower than with ECT. Our clinical question encompasses piloting a maintenance TMS regimen to maintain remission in treatment-resistant major depressive disorder. This will be a patient-preference clinical trial, with patients offered the choice to initiate maintenance TMS versus maintenance ECT after their index ECT sessions for treatment-resistant depression. There will be no randomization or placebo involved in this study.

Eligibility Criteria

This trial is for individuals with treatment-resistant major depressive disorder who have already undergone electroconvulsive therapy (ECT). Participants should prefer and be able to attend outpatient sessions, as they will choose between maintenance Transcranial Magnetic Stimulation (TMS) or continuing ECT.

Inclusion Criteria

Able to provide informed consent

I am between 18 and 65 years old.

Right-handed

See 2 more

Exclusion Criteria

I have a history of seizures or a seizure disorder.

Related neurological disorder, or any other medical condition that would preclude TMS treatment determined by the treatment team.

Treatment Details

Interventions

Transcranial Magnetic Stimulation (Behavioural Intervention)

Trial OverviewThe study tests if maintenance TMS can effectively maintain remission in patients with treatment-resistant depression compared to the standard maintenance ECT. It's a patient-preference trial, meaning participants choose their treatment without random assignment.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: TMSExperimental Treatment1 Intervention

Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. They will receive TMS in this arm of study for maintenance treatment of their depression and monitored with depressive scales.

Group II: ECTActive Control1 Intervention

Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. If they elect to continue with maintenance ECT treatments which is the current standard of care, their depressive symptoms and cognitive functioning will be monitored accordingly.

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for: