NCT04243798

Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation

Utilizing Changes in Human Brain Connectivity to Establish a Dose-response Relationship Involved in the Therapeutic Actions of Prefrontal Brain Stimulation on Depression Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

Detailed description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, we have pursued modifying the treatment parameters to reduce treatment times with an accelerated treatment paradigm with great preliminary success. This study aims to further study our accelerated protocol and examine changes in neuroimaging biomarkers. Dr. Nolan Williams is the Principle Investigator on the grant associated for this study and so is listed as Study Director on the study record.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DEVICE	Active TBS-DLPFC	Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004). Stimulation will be delivered to the L-DLPFC using a MagPro x100 TMS system (MagVenture, Denmark).
DEVICE	Sham TBS-DLPFC	The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.

Timeline

• Start date: 2021-06-15
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2020-01-28
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study