NCT05144789

Personalized Therapeutic Neuromodulation for Anhedonic Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the anti-anhedonic efficacy of a novel neurostimulation strategy termed accelerated intermittent theta burst stimulation (aiTBS) in participants with treatment resistant depression (TRD).

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, the investigators have pursued modifying the treatment parameters to reduce treatment times with an accelerated treatment paradigm. This study aims to further study the accelerated protocol and examine changes in neuroimaging biomarkers.

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 TMS system (MagVenture, Denmark).
DEVICE	Active TBS-DMPFC	Participants in the active stimulation group will receive intermittent TBS to DMPFC. The DMPFC 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 DMPFC using a MagPro TMS system (MagVenture, Denmark).
DEVICE	Sham TBS-DLPFC or DMPFC	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: 2022-05-31
• Primary completion: 2025-06-06
• Completion: 2025-12-31
• First posted: 2021-12-03
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study