Testing a Transdiagnostic TMS Treatment Target

NCT06282146 | Active Not Recruiting Early Phase 1 FDA Device

• 1 other identifier: 2024P000252
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.

Conditions

Major Depressive Disorder; Depression; Psychiatric Disorder; Mood Disorders; Mental Disorder; Anxiety Disorders; OCD; PTSD

Outcome Measures

Primary Outcomes (2)

• Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire

  Questionnaire asking about the incidence, frequency, and severity of common TMS-related side effects such as headache, tinnitus, and neck pain. Higher severity and frequency of side effects indicates lower tolerability

  Each morning before treatment and afternoon after treatment during the 5 days of treatment

• Feasibility as measured by number of the 50 treatments completed

  0-50 treatments more treatments completed: higher feasibility

  Throughout the 5 days of treatment

Secondary Outcomes (3)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  Before treatment and two weeks after treatment ends

• Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC)

  Before treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment

• World Health Organization Disability Assessment Schedule II (WHODAS 2.0)

  Before treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment

Other Outcomes (15)

• Beck Depression Inventory (BDI)

  Before treatment, daily throughout treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment

• Beck Anxiety Inventory (BAI)

  Before treatment, daily throughout treatment and two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment

• Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS)

  Before treatment and two weeks after treatment

Study Arms (1)

Open-label aiTBS to posterior parietal cortex

EXPERIMENTAL

10 iTBS treatment sessions per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total). In the unlikely event that a participant is late for an hourly treatment, then the treatment will be delayed accordingly. The minimum gap between treatments will be 25 minutes. Each iTBS treatment will consist of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation will be delivered at 90% resting motor threshold (rMT), adjusted for depth of the identified functional connectivity target.

Procedure: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation PROCEDURE

non-invasive form of brain stimulation

Also known as: TMS, accelerated intermittent theta burst stimulation, aiTBS

Open-label aiTBS to posterior parietal cortex

Eligibility Criteria

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

You may qualify if:

• Age 18-65
• English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
• Diagnosis of MDD per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders) and currently experiencing a moderate to severe episode:
• \>20 on Beck Depression Inventory (BDI)
• \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) 14, 15
• Moderate to severe level of treatment resistance (Maudsley Staging Method)16, 17
• Diagnosis of at least one or more of the following psychiatric conditions per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders):
• Generalized anxiety disorder (GAD), panic disorder (PD), or social anxiety disorder (SAD)
• Obsessive compulsive disorder (OCD)
• Post-traumatic stress disorder (PTSD)
• Physician referral for individuals with either schizophrenia or schizoaffective disorder
• Stable psychiatric medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the two-week post-treatment visit
• Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
• Agreement to lifestyle considerations
• Abstain from becoming pregnant from time of screening to two weeks after treatment (post-treatment MRI visit)

You may not qualify if:

• Active pregnancy as determined by a urine pregnancy test
• Positive urine drug screen for illicit substances (not including THC)
• Depressive symptoms refractory to 8 sessions of electroconvulsive therapy (ECT)
• Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)
• Receiving or planning to receive other TMS treatments during course of participation
• History of
• Autism spectrum disorder
• Neurosurgical intervention for depression
• Intellectual disability
• Severe cognitive impairment
• Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion)
• Untreated or insufficiently treated endocrine disorder
• Treatment with investigational drug or intervention during the study period
• Depth-adjusted TMS treatment dose \> 65% maximum stimulator output
• Existing tinnitus (ringing in the ears)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Mental Disorders; Mood Disorders; Anxiety Disorders; Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Joseph J Taylor, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Psychiatry

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 28, 2024
• Study Start: September 9, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)