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Maintenance TMS in Treatment Resistant Depression

NCT06682299 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-05-12

Study results available
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Summary

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.

Conditions

  • Treatment Resistant Depression (TRD)

Interventions

DEVICE

Transmagnetic Stimulation

TMS will be given for the maintenance treatment of treatment resistant depression following successful course of ECT (8-12 treatments).

DEVICE

Electroconvulsive Therapy

Patients will remain in standard of care treatment and receive maintenance ECT treatments for treatment resistant depression

Sponsors & Collaborators

  • Austin Messner

    lead OTHER

Principal Investigators

  • Gopalkumar Rakesh, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2025-06-26
Completion
2025-06-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682299 on ClinicalTrials.gov