Symptom-specific TMS Targets for Depression and Anxiety

NCT04604210 | Completed Phase 2 FDA Device

• 1 other identifier: 2020P002296
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to compare two different treatment targets for transcranial magnetic stimulation, an FDA-approved treatment for major depressive disorder (MDD), in terms of their relative efficacy for depression versus anxiety.

Conditions

Depression; Anxiety; Major Depressive Disorder

Keywords

TMS; Transcranial; Neuromodulation; Brain stimulation; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Beck Anxiety Inventory (BAI)

  The primary outcome will be the rank-transformed ratio of BDI change to BAI change

  Baseline (before treatment), 3 weeks (after 15 treatments), and 6 weeks (after 30 treatments)

• Beck Depression Inventory (BDI)

  The primary outcome will be the rank-transformed ratio of BDI change to BAI change

  Baseline (before treatment), 3 weeks (after 15 treatments), and 6 weeks (after 30 treatments)

Secondary Outcomes (6)

• Resting-state functional MRI (rsfMRI) scan

  Baseline (before treatment) and 6 weeks (after 30 treatments)

• Temperament and Character Inventory, Revised 140-item (TCI-R 140)

  Baseline (before treatment) and 6 weeks (after 30 treatments)

• NIH Toolbox cognitive battery

  Baseline (before treatment) and 6 weeks (after 30 treatments)

• Multidimensional task-based emotional assessment

  Baseline (before treatment) and 6 weeks (after 30 treatments)

• Pain at the stimulation site

  Baseline (before treatment) and 6 weeks (after 30 treatments)

Study Arms (2)

Dysphoric target

EXPERIMENTAL

The "dysphoric" target is a region in the dorsolateral prefrontal cortex. TMS targeted to this region has been shown to be more effective for depression than anxiety.

Procedure: Transcranial magnetic stimulation

Anxiosomatic target

EXPERIMENTAL

The "anxiosomatic" target is a region in the dorsomedial prefrontal cortex. TMS targeted to this region has been shown to be more effective for anxiety than depression.

Procedure: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation PROCEDURE

Transcranial magnetic stimulation (TMS) is a noninvasive FDA-approved technique that is commonly used as a treatment for depression. It has been shown to focally activate specific brain regions that are believed to be underactive in patients suffering from depression. In this study, TMS will be administered within FDA-approved guidelines under the supervision of a physician with experience in administering the treatment and monitoring for complications.

Also known as: TMS

Anxiosomatic target; Dysphoric target

Eligibility Criteria

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

You may qualify if:

• Adults age 18 to 65
• Meeting FDA guidelines for clinical TMS (DSM-5 diagnosis of major depressive disorder with at least one failed antidepressant trial)1
• Beck Depression Inventory (BDI) score of 20 or higher
• Beck Anxiety Inventory (BAI) score of 16 or higher

You may not qualify if:

• History of:
• Moderate or severe substance use disorder in the past six months as defined by DSM-5 criteria, with the exception of cannabis and nicotine use disorders.
• Dementia, as defined by treating neurologist
• Moderate or severe autism spectrum disorder
• Bipolar disorder
• Schizophrenia spectrum disorders
• Current evidence of:
• Substance-induced mood disorder
• Active psychotic symptoms
• Active suicidal ideation
• Contraindications to rTMS treatment:
• Seizure disorder
• Significantly elevated seizure risk, as determined by clinician assessment
• Presence of metallic objects within the head
• Presence of an implanted neurostimulation device within the head

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Shan H Siddiqi, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to which target is expected to improve which symptom. Study investigators (with the exception of the treatment administrator), including the outcomes assessor, will be blinded to which participant is receiving which treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel-group double-blind randomized, controlled trial

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 27, 2020
• Study Start: February 3, 2021
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

US (1)