Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder

NCT ID: NCT04076644

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-09-01

Brief Summary

This an open label study using a FDA-cleared TMS stimulation protocols which will be used to treat patients who have responded or remitted from depression using acute clinical TMS therapy at the University of Missouri-Columbia Neuromodulation Clinic. TMS therapy will be given to subjects at monthly intervals. Depression severity questionnaires will be given monthly to determine if the subjects original response to TMS can be maintained. Subjects will be tapered down from antidepressant medication prior to TMS maintenance treatment. Results will be analyzed to determine the effectiveness and feasibility of maintenance TMS therapies in a clinical setting.

Detailed Description

This an open label study using Transcranial Magnetic Stimulation (TMS) as a maintenance treatment for subjects that have seen a clinically significant response or remission from their depressive symptoms after having had an acute clinical course of TMS. All potential subjects must have been treated at the University of Missouri Columbia Neuromodulation Clinic to qualify.

There are 2 arms in this study. The first is a group of patients who will not receive any TMS treatments and will be followed for a year, and have their depression severity assessed monthly using the Personal Health Questionnaire (PHQ9), and the Quick Inventory of Depressive Symptoms.

The second arm will receive TMS treatments 5 times/month for 12 months, be assessed for changes in depressive symptom severity monthly using the PHQ9 and QIDS. TMS treatment protocols will consist of wither the standard 20min 10Hz protocol, or a 3min theta-burst protocol. The protocol used will be determined by what worked for the subject when they were treated clinically at the University of Missouri Columbia Neuromodulation clinic. Subjects in this arm will be tapered of antidepressant medication prior to monthly TMS treatment and will remain antidepressant free for the duration of the study.

The study will be a year long in duration.

Conditions

MDD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMS Treatment Arm

Subjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9.

Group Type: ACTIVE_COMPARATOR

TMS treatment

Intervention Type: DEVICE

TMS using either a standard 10hz 20min or 3 min theta burst protocol

No TMS Arm

Subjects will be followed and assessed for depressive symptoms at monthly time intervals similar to the active treatment arm using QIDS and PHQ9. This group does not receive TMS treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TMS treatment

TMS using either a standard 10hz 20min or 3 min theta burst protocol

Intervention Type: DEVICE

Other Intervention Names

Transcranial Magnetic Stimulation

Eligibility Criteria

Inclusion Criteria

• Must have recently (within 4 weeks) completed an acute TMS course (full 36 treatments) at the University of Missouri Columbia Neuromodulation clinic
• Must have clinically responded to the acute TMS treatment course (≥50% improvement according to the clinical depressive scale used - usually the PHQ-9)
• Must be able sign consent
• Must have a current address and phone number
• Must have current mental health care provider, either psychiatrist or general practioner who they see for mental health symptom management
• Must be able to taper off antidepressant medication before 1st monthly treatment block (treatment group only)

Exclusion Criteria

• - Subject that has not completed a full acute treatment course, including taper
• Subjects that have changed anything that may not make them safe for TMS, which are (all changes will be reviewed by study MD, and will not necessarily be excluded possibly depending on severity):

• Any new metal near head
• Any new medical devices that cannot be removed
• Any new pregnancies (verbally confirmed)
• Seizures that occurred post-acute TMS treatment
• Any uncontrolled cardiovascular disease
• Any new head trauma
• Any new illness causing injury to brain
• Any new medications which cannot be altered or lowered that may be contraindicated for TMS treatment
• Any drug or alcohol use deemed by the study doctor as unsafe for TMS treatment
• Subjects unwilling to sign consent or follow study procedures
• Subjects with known extended travel plans which may affect study procedures and scheduled TMS treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Muaid Ithman

Associate Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muaid Ithman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri Neuromodulation Center

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2013884

Identifier Type: -

Identifier Source: org_study_id