Maintenance TMS in Treatment Resistant Depression

NCT06682299 | Recruiting DMC FDA Device

• 1 other identifier: 95789
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

depression; tms; ect; treatment resistant depression; trd

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale (HDRS)

  One of the most widely used clinician administered depression scales containing 17 items. Scores range from 0 to 54 with 0-7 being normal, 8-16 being mild depression, 17-23 moderate depression and 24 or greater being severe depression. Higher scores equate to more severe depressive symptoms.

  Baseline and prior to each procedure for duration of study, up to six months

Secondary Outcomes (2)

• Change in Quick inventory of depressive symptomatology (QIDS)

  Baseline and prior to each procedure for duration of study, up to six months

• Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)

  Baseline on initial presentation, at 6 months, and at 12 months

Study Arms (2)

TMS

EXPERIMENTAL

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.

Device: Transmagnetic Stimulation

ECT

ACTIVE COMPARATOR

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.

Device: Electroconvulsive Therapy

Interventions

Transmagnetic Stimulation DEVICE

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

Also known as: TMS

TMS

Electroconvulsive Therapy DEVICE

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

Also known as: ECT

ECT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated for TRD who have achieved remission through an index series of ECT
• Able to provide informed consent
• Age between 18 and 65 years
• Deemed appropriate for maintenance TMS by their psychiatrist
• Right-handed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Austin Messner: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40509, United States

RECRUITING

Related Publications (4)

• Rachid F. Safety and Efficacy of Theta-Burst Stimulation in the Treatment of Psychiatric Disorders: A Review of the Literature. J Nerv Ment Dis. 2017 Nov;205(11):823-839. doi: 10.1097/NMD.0000000000000742.

  PMID: 29077650 BACKGROUND

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

• Wilson S, Croarkin PE, Aaronson ST, Carpenter LL, Cochran M, Stultz DJ, Kozel FA. Systematic review of preservation TMS that includes continuation, maintenance, relapse-prevention, and rescue TMS. J Affect Disord. 2022 Jan 1;296:79-88. doi: 10.1016/j.jad.2021.09.040. Epub 2021 Sep 17.

  PMID: 34592659 BACKGROUND

• Magnezi R, Aminov E, Shmuel D, Dreifuss M, Dannon P. Comparison between neurostimulation techniques repetitive transcranial magnetic stimulation vs electroconvulsive therapy for the treatment of resistant depression: patient preference and cost-effectiveness. Patient Prefer Adherence. 2016 Aug 4;10:1481-7. doi: 10.2147/PPA.S105654. eCollection 2016.

  PMID: 27536079 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression; Epilepsy, Rolandic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Gopalkumar Rakesh, MD

  University of Kentucky

  STUDY DIRECTOR

Central Study Contacts

Austin R Messner, MD

CONTACT

859-323-6861; austin.messner@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Medical Resident

Model Details: Open label patient preference trial

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: April 17, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

US (1)