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Frequency and E-field Enhancement of ITBS for Depression (FREED) (FREED)

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ClinicalTrials.gov Identifier: NCT06003309
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : March 1, 2024
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Zafiris Daskalakis, University of California, San Diego

Study Description
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Brief Summary:
The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully Individualized form of intermittent Theta Burst Stimulation (iTBS) (using BOTH the frequency and electric field (E-field) targeting approaches) (Ind-iTBS)), (2) iTBS individualized using E-field targeting only (targeted-iTBS) and (3) Standard iTBS treatment (i.e., typical iTBS localized to the dorsolateral prefrontal cortex (DLPFC) using the Beam F3 method). Electroencephalography (EEG) data will be collected at rest and during a working memory task, at baseline, and at the end of treatment along with clinical assessments of depression severity. The target engagement dependent variable of interest in these three arms will be fronto-parietal theta connectivity measured through resting-state EEG. The investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS. Aim: To evaluate the effects of two individualized forms of iTBS (i.e., using BOTH the frequency and E-field individualization; Ind-iTBS) compared to iTBS individualized for E-field targeting only (targeted-iTBS) and standard iTBS on fronto-parietal theta connectivity. Hypotheses: (1) Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity compared to both targeted-iTBS and standard iTBS. (2) Ind-iTBS will also lead to a greater reduction in depressive symptoms (as defined by the mean reduction in Montgomery Åsberg Depression Rating Scale Scores (MADRS)) compared to both targeted-iTBS and standard iTBS.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS Device: Transcranial Magnetic Stimulation (TMS) - targeted-iTBS Device: Transcranial Magnetic Stimulation (TMS) - Standard-iTBS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Frequency and E-field Enhancement of ITBS for Depression (FREED)
Actual Study Start Date : August 31, 2023
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: The fully individualized form of iTBS (BOTH the frequency and E-field targeting approaches)
In the Ind-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting. The stimulation frequency will also be individualized according to EEG-derived TGC.
 Device: Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS
Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for TRD that is increasingly being used in clinical practice across the world. It's mechanism of action is based on Farady Law of electromagnetic induction where the magnetic field produced by TMS coil induces electric field in the neurons. In the Ind-iTBS, the coil placement and current amplitude will be provided using individualized E-field modelling and coordinate-based cortical targeting. The stimulation frequency will also be individualized according to EEG-derived TGC.
Active Comparator: iTBS individualized using E-field targeting only (targeted-iTBS)
In the targeted-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting.
 Device: Transcranial Magnetic Stimulation (TMS) - targeted-iTBS
Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for TRD that is increasingly being used in clinical practice across the world. It's mechanism of action is based on Farady Law of electromagnetic induction where the magnetic field produced by TMS coil induces electric field in the neurons. In the targeted-iTBS, the coil placement and current amplitude will be provided using individualized E-field modelling and coordinate-based cortical targeting.
Active Comparator: Standard iTBS treatment (i.e., typical iTBS localized to the DLPFC using the Beam F3 method)
The standard iTBS will be delivered with the typical 5Hz/50Hz patterned frequencies used in the FDA-approved treatment protocol and stimulation will be delivered according to the Beam F3 targeting.
 Device: Transcranial Magnetic Stimulation (TMS) - Standard-iTBS
Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for TRD that is increasingly being used in clinical practice across the world. It's mechanism of action is based on Farady Law of electromagnetic induction where the magnetic field produced by TMS coil induces electric field in the neurons. The standard iTBS will be delivered with the typical 5Hz/50Hz patterned frequencies used in the FDA approved treatment protocol and stimulation will be delivered according to the Beam F3 targeting.


Outcome Measures
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Primary Outcome Measures :
  1. Change from pre-treatment in fronto-parietal theta connectivity at post-treatment [ Time Frame: pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment) ]
    Source-localized fronto-parietal theta connectivity will be calculated from resting EEG


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder disorder.
  • 18-80 years of age.
  • Male or female.
  • At least one failed antidepressant medication trial at level 3 in the Antidepressant Treatment History Form: Short Form (ATHF-SF) classification.
  • Montgomery-Asberg Depression Rating Scale (MADRS) Score of >19 (moderate - severe depression).
  • No increase or initiation of new antidepressant therapy in the four weeks prior to screening.
  • Demonstrated capacity to give informed consent.

Exclusion Criteria:

  • Inability to provide informed consent.
  • Medically unstable patients.
  • Concomitant neurological disorder or a history of a seizure disorder.
  • Patients who are pregnant or breastfeeding.
  • Any psychotic disorder or current active psychotic symptoms.
  • Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.
  • Contraindication to MRI scanning.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06003309


Contacts
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Contact: Interventional Psychiatry 858-207-0938 iptrials@health.ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Jessica Rico    858-966-5832    iptrials@health.ucsd.edu   
Contact: Bianca Bacio    858-657-6152    bbacio@health.ucsd.edu   
Principal Investigator: Zafiris Daskalakis, MD, PhD, FRCP         
Australia
Australian National University Recruiting
Canberra, Australia, 2601
Contact: Shona Brinley       shona.brinley@anu.edu.au   
Principal Investigator: Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP         
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
More Information
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Responsible Party: Zafiris Daskalakis, Chair of Psychiatry Department, University of California, San Diego
ClinicalTrials.gov Identifier: NCT06003309    
Other Study ID Numbers: 807836
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: March 1, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders