Transcranial Magnetic Stimulation vs Theta Burst Stimulation in Major Depressive Disorder

September 26, 2022 updated by: Neurological Associates of West Los Angeles

A Blinded, Randomized Trial Comparing the Effects of Transcranial Magnetic Stimulation and Theta Burst Stimulation in Patients With Major Depressive Disorder

The purpose of this study is to investigate the differences in efficacy between transcranial magnetic stimulation (TMS) and intermittent theta burst stimulation (iTBS) treatment in subjects suffering from major depressive disorder.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Up to 30 patients of any gender aged from 18 to 70 years old will be recruited for inclusion once candidacy has been established by screening criteria.

Once recruited, patients will be randomly assigned to the TMS treatment group or the iTBS treatment group. Patients will be blinded to their group assignment, but will be informed of their assignment upon the final outcome measure collection timepoint (e.g., 1 month post-treatment). Patients who failed to respond by 1-month post iTBS or TMS treatment will be allowed to cross-over into the other treatment group and will be re-enrolled into the study.

For patients assigned to the TMS treatment group, the treatment protocol will consist of 20 sessions of TMS treatment. Each TMS session will deliver 5,000 pulses (120-140% MT, continuous temperature of 24C) over an 61 minute, 51 second time period. Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.

For patients assigned to the iTBS treatment group, the treatment protocol will consist of 20 sessions of iTBS treatment. Each iTBS session will deliver 1,800 pulses (120-140% MT, continuous temperature of 24C) over an 9-minute-40-second period. Patients will have up to four iTBS sessions per day, five days a week, until their treatment is completed (approximately 1 week). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.

Study Type

Interventional

Enrollment (Anticipated)

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

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Neurological Associates of West Los Angeles

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder
  • Score greater than 13 on the Beck Depression Inventory
  • Failure to remit with 3 antidepressants
  • At least 18 years of age
  • Must be willing to comply with the study protocol
  • English Proficiency

Exclusion Criteria:

  • Hepatic impairment
  • Significant cytopenia
  • Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis
  • Advanced terminal illness
  • Any active cancer or chemotherapy
  • Bone marrow disease
  • Neurodegenerative diseases
  • Myeloproliferative disorders
  • Sickle cell disease
  • Subjects with scalp rash or open wounds on the scalp
  • Women who are pregnant, may become pregnant, or are breastfeeding
  • Subjects unable to give informed consent or in vulnerable categories, such as prisoners
  • Subjects who would not be able to lay down without excessive movement
  • Recent surgery or dental work within 3 months of the scheduled procedure
  • Not English Proficient
  • Advanced stages of any terminal illness or any active cancer that requires chemotherapy
  • History of epilepsy or seizure, or history of such in first degree relative
  • An increased risk of seizure for any reason
  • Stents in the neck or brain
  • Aneurysm clips or coils
  • Metal devices/objects in or near the head
  • Metallic implants near the ears and eyes
  • Facial tattoos with metallic or magnetic-sensitive ink
  • Comorbid psychiatric conditions

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Magnetic Stimulation
All patients are required to have an advanced MRI of the brain including a structural T1, volume measurements of various brain regions, ASL, and BOLD sequences. Patients will also undergo an in-scanner task designed to activate key neurofunctional regions of interest.
Device: Transcranial Magnetic Stimulation
5,000 pulses (120-140% MT, continuous temperature of 24C) will be delivered per session (see Appendix A for timing parameters). Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks).
Experimental: Theta Burst Stimulation
All patients are required to have an advanced MRI of the brain including a structural T1, volume measurements of various brain regions, ASL, and BOLD sequences. Patients will also undergo an in-scanner task designed to activate key neurofunctional regions of interest.
Device: Theta Burst Stimulation
One session of iTBS will deliver 1,800 pulses (120-140% MT, continuous temperature of 22ºC) over an 9-minute-40-second period. The minimum break period between iTBS sessions is 25 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI-II)
Time Frame: 1 month
The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
1 month
Patient Depression Questionnaire (PDQ-9)
Time Frame: 1 month
The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
1 month
Hamilton Depression Rating Scale (HAM-D)
Time Frame: 1 month
The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.
1 month
Global Rating of Change (GRC)
Time Frame: 1 month
The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI-II)
Time Frame: 2 months
The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
2 months
Patient Depression Questionnaire (PDQ-9)
Time Frame: 2 months
The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
2 months
Hamilton Depression Rating Scale (HAM-D)
Time Frame: 2 months
The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.
2 months
Global Rating of Change (GRC)
Time Frame: 2 months
The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.
2 months

Collaborators and Investigators

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

Sponsor

Neurological Associates of West Los Angeles

Investigators

  • Principal Investigator: Sheldon E Jordan, M.D., Neurological Associates of West Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 6, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20193262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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