Transcranial Magnetic Stimulation vs Theta Burst Stimulation in Major Depressive Disorder

NCT04497350 | Unknown FDA Device

• 1 other identifier: 20193262
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

transcranial magnetic stimulation; theta burst stimulation

Outcome Measures

Primary Outcomes (4)

• Beck Depression Inventory (BDI-II)

  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)

  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)

  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)

  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 Outcomes (4)

• Beck Depression Inventory (BDI-II)

  2 months

• Patient Depression Questionnaire (PDQ-9)

  2 months

• Hamilton Depression Rating Scale (HAM-D)

  2 months

• Global Rating of Change (GRC)

  2 months

Study Arms (2)

Transcranial Magnetic Stimulation

EXPERIMENTAL

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

Theta Burst Stimulation

EXPERIMENTAL

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

Interventions

Transcranial Magnetic Stimulation DEVICE

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).

Transcranial Magnetic Stimulation

Theta Burst Stimulation DEVICE

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.

Theta Burst Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates of West Los Angeles

Santa Monica, California, 90403, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sheldon E Jordan, M.D.

  Neurological Associates of West Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-site, randomized, blinded, clinical trial comparing the efficacy of transcranial magnetic stimulation (TMS) and intermittent theta burst stimulation (iTBS) in subjects with treatment refractory depression (trMDD). The study will recruit 30 subjects, all suffering from treatment refractory depression (trMDD). Half of the subjects (15) will be randomized to the TMS treatment group, while the other half will be assigned to the iTBS treatment group. The randomization ratio will be 1:1.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: August 4, 2020
• Study Start: January 6, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)