Symptom-specific TMS Targets for Depression and Anxiety

Depression Clinical Trial

Official title:

A Pilot Randomized Trial of Distinct Symptom-specific Targets for Transcranial Magnetic Stimulation in Patients With Depression and Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604210
• Other study ID #: 2020P002296
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2021
• Est. completion date: December 28, 2023

Study information

• Verified date: January 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	Resting-state functional MRI (rsfMRI) scan	Functional MRI scan will be conducted before and after treatment in order to assess for treatment-induced changes in brain connectivity	Baseline (before treatment) and 6 weeks (after 30 treatments)
Secondary	Temperament and Character Inventory, Revised 140-item (TCI-R 140)	Psychobiologically-based personality inventory which measures seven personality dimensions (harm avoidance, novelty seeking, reward dependence, persistence, self-directedness, cooperativeness, and persistence). For each dimension, this yields a scaled T-score (mean score of 50 with standard deviation of 10). This is an overall estimate of personality traits, and there are no "better" or "worse" traits.	Baseline (before treatment) and 6 weeks (after 30 treatments)
Secondary	NIH Toolbox cognitive battery	An interactive computerized battery of cognitive tasks which is used to compute an overall index of crystallized and fluid cognition. For each cognitive subscale, this yields a scaled T-score (mean score of 100 with standard deviation of 10).	Baseline (before treatment) and 6 weeks (after 30 treatments)
Secondary	Multidimensional task-based emotional assessment	An interactive computerized battery of emotional tasks, including Aversion-Reward Conflict, Emotion Conflict Resolution, Multiple Source Interference, Fear Conditioning/Extinction, Gambling, and Associative Learning Tasks. Each task will yield results for accuracy and reaction time.	Baseline (before treatment) and 6 weeks (after 30 treatments)
Secondary	Pain at the stimulation site	Participants will be asked to rate treatment-induced pain/discomfort on a scale of 1 to 10	Baseline (before treatment) and 6 weeks (after 30 treatments)
Secondary	Multidimensional battery of emotional questionnaires	A computerized battery of questionnaires including the Anxiety Sensitivity Index, Adult Temperament Questionnaire, Emotion Reactivity Scale, Barratt Impulsivity Scale, Adult ADHD Self-Rating Scale, Brief Inventory of Executive Functioning. Each scale yields a raw score.	Baseline (before treatment) and 6 weeks (after 30 treatments)