Boston,
Massachusetts
02115
Purpose:
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.
Study summary:
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.
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