Intermittent Theta Burst Stimulation for MDD (iTBS)

September 29, 2023 updated by: Andrew F. Leuchter, University of California, Los Angeles

A Sham-controlled Study of Prefrontal Intermittent Theta Burst Stimulation in Major Depressive Disorder

This study will evaluate the effectiveness of intermittent Theta Burst Stimulation for patients with Major Depressive Disorder.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

The purpose of this research study is to evaluate the effectiveness and efficacy of intermittent Theta Burst Stimulation (iTBS) for treatment of Major Depressive Disorder (MDD). Subjects will be randomly assigned to two weeks (10 sessions) of treatment with open-label iTBS, blinded iTBS or blinded sham. 'Open-label' means that you (the subject) and the study staff will know that you are receiving active iTBS treatment. 'Blinded' or 'sham-controlled' means that you, the subject, will not know whether the treatment you receive is the active treatment or the non-active treatment. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating your brain. Subjects who do not show remission of symptoms after the first 2 weeks of treatment will receive 10 additional treatment sessions with open-label active iTBS. Subjects will be evaluated at Week 12 to assess the durability of symptoms changes.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90025
        • UCLA TMS Clinic and Research Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) assessed via the MINI structured interview
  2. Must have been on a stable dose of antidepressant medication (excluding tricyclic antidepressants) for at least 1 month prior to randomization, and with significant residual MDD symptoms as evidenced by a HamD17 score > 17;
  3. If receiving medication other than for depression (e.g., anxiety, sleep, mood stabilization), must have been on stable dose for at least 1 month prior to randomization
  4. A history of treatment failure with at least one adequate trial of an antidepressant medication in the current episode, assessed by the Antidepressant Treatment and History Form
  5. Age range: 22-65.

Exclusion Criteria:

  1. Patient is mentally or legally incapacitated, unable to give informed consent.
  2. Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current Mini Mental State Examination ≤ 24; delirium or substance abuse within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
  3. Patients with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal ideas or gestures" or "attempts at suicide," will be excluded.
  4. Patients with exposure to Electroconvulsive Therapy within the past 6 months, previous TMS treatment for any condition, or Vagus Nerve Stimulation treatment (lifetime).
  5. Patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
  6. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, Cerebral Vascular Accident, or Transient Ischemic Attacks; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
  7. Any history of intracranial implant including cochlear implant, implanted electrodes/stimulators, aneursym clips or coils, stents, bullet fragments; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
  8. Neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or with primary or secondary tumors in the Central Nervous System.
  9. current pregnancy, breast feeding, or not using a medically accepted means of contraception.
  10. Infection or loss of integrity of skin over the forehead, where the device will be positioned.
  11. Increased risk of seizure as indicated by: a) history (or family history) of seizure or epilepsy; b) history of stroke, head injury, or unexplained seizures; c) concurrent medication use such as tricyclic antidepressants, neuroleptic medications, or other drugs that are known to lower the seizure threshold; d) secondary conditions that may significantly alter electrolyte balance or lower seizure threshold; e) no quantifiable motor threshold such that TMS dosage cannot be accurately determined.
  12. Other medical contraindications to any of the study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label

Theta burst stimulation (TBS) is a form of repetitive transcranial magnetic stimulation (TMS). Standard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session.

Each treatment session thus involves < 10 minutes of stimulation. The subject and researchers know what treatment is being administered.

Transcranial magnetic stimulation system
Active Comparator: Blinded Active

Standard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session.

Each treatment session thus involves < 10 minutes of stimulation. The subject and researcher will not know what type of treatment will be administered.

Transcranial magnetic stimulation system
Sham Comparator: Blinded Sham

This is a sham treatment which will mimic the open-label and blinded active to enable the effects of the supposedly "active" treatment to be assessed objectively. The subject and researcher will not know what type of treatment will be administered.

Each treatment session will be < 10 minutes in duration.

Transcranial magnetic stimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in Hamilton Depression Scale (HamD17)
Time Frame: two week
two week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2017

Primary Completion (Estimated)

December 8, 2023

Study Completion (Estimated)

December 8, 2023

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimated)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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