Symptom-specific TMS Targets for Depression and Anxiety

NCT ID: NCT04604210

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2023-12-28

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.

Detailed Description

Transcranial magnetic stimulation (TMS) is a safe, noninvasive FDA-cleared technique that is commonly used as a treatment for MDD. It has been shown to focally activate specific brain regions that are believed to be underactive in these patients. This study aims to compare two different TMS targets in the prefrontal cortex. TMS will be administered within FDA-approved guidelines under the supervision of a physician with experience in administering the treatment and monitoring for complications.

This will be a prospective double-blind randomized controlled trial to assess the comparative efficacy of two different TMS targets within the prefrontal cortex (PFC). The "dysphoric" target in the dorsolateral PFC is believed to be more effective for depression, while the "anxiosomatic" target in the dorsomedial PFC is believed to be more effective for anxiety.

Patients with comorbid depression and anxiety will receive 6 weeks of TMS following standard clinical parameters (30 treatments over 6 weeks, 10 Hz frequency, 3000 pulses) with MRI-guided neuronavigation. Participants will be randomized to either the dysphoric or anxiosomatic target. Both targets are believed to be effective treatments for this patient population. Participants and raters will remain blinded to the group assignment. All participants will receive resting-state functional MRI scans before and after the course of treatment in order to study physiological changes.

The dysphoric target is expected to induce greater relative improvement in depression, while the anxiosomatic target is expected to induce greater relative improvement in anxiety.

Conditions

Depression; Anxiety; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dysphoric target

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.

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: 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.

Anxiosomatic target

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.

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: 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.

Interventions

Transcranial magnetic stimulation

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.

Intervention Type: PROCEDURE

Other Intervention Names

TMS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Contraindications to MRI

• Severe claustrophobia
• Severe pain/illness exacerbated by lying prone in the scanner
• Presence of non-MRI compatible metal foreign bodies or implants
• Weight in excess of 350 lbs
• Shoulder width in excess of maximum tolerable width for scanner

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shan Siddiqi, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shan H Siddiqi, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P002296

Identifier Type: -

Identifier Source: org_study_id