Compressed Intermittent Theta Burst Stimulation

NCT04684706 | Active Not Recruiting FDA Device

• 1 other identifier: 834723
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

In this proposal the investigators will use an accelerated TMS protocol that concentrates the magnetic stimulation that would usually occur over 6 weeks into 10 treatment sessions per days, for 5 consecutive days in patient with treatment-refractory depression. This protocol will build on a previously published study demonstrating clinical efficacy of intermittent theta-burst stimulation (iTBS) on left dorsolateral prefrontal cortex (L-dlPFC) in a treatment refractory population.

Conditions

Treatment Resistant Depression

Keywords

TMS; fMRI

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms Change

  Depressive symptoms will be measured before and after treatment by means of the clinician-administered Montgomery Asberg Depression Rating Scale (MADRS) (0-60, lower scores indicate lower depressive symptoms) and the self report Beck Depression Inventory (BDI II) (0-30, lower scores indicate lower depressive symptoms). Change will be measured by comparing measurements pre- and post- on the same measures. The bigger the change, the bigger the reduction in depressive symptoms.

  2 Weeks

Secondary Outcomes (1)

• Self report Symptom Change

  2 weeks

Study Arms (1)

Compressed iTBS schedule

OTHER

Stimulation 3-pulse 50-Hz bursts at 5-Hz for 2-s trains, with trains every 10 s, for 10 minutes, 10 times a day, for 5 consecutive days.

Device: intermittent Theta Burst Stimulation

Interventions

intermittent Theta Burst Stimulation DEVICE

The present study will utilize TMS dosage of iTBS of 18 000 pulses a day for 5 consecutive days.

Compressed iTBS schedule

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender, inclusive
• years of age
• Meets Diagnostic and Statistical Manual of Mental Disorders criteria for primary diagnosis of MDD
• Patients must be fluent in English
• Participants must have the ability to provide consent
• Montgomery Asberg Depression Rating Scale score ≥20
• Failed 2+ prior treatments (treatment-refractory)
• May be on current anti-depressant medication at the discretion of PI, if not exceeding doses that would make TMS an increased risk

You may not qualify if:

• Pregnancy (Female participants)
• MRI contraindication
• Medical condition that interferes with the collection or interpretation of MRI data
• Implanted devices such as: aneurysm clip or cardiac pacemaker
• Diagnosis of stroke, epilepsy, or other neurological disorders interfering with treatment at PI discretion
• Any factor the investigator believe may affect participant safety or compliance (ex: ≥100 miles from clinic)
• Current alcohol or substance use disorder in last 3 months

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Department of Interventional Psychiatry, University of California San Diego

La Jolla, California, 92093, United States

Location

Center for Neuromodulation in Depression and Stress

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Yvette Sheline, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Neuromodulation in Depression and Stress (CNDS)

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: December 24, 2020
• Study Start: February 20, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)