CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Active TBS-DLPFC +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03068715
NCT03068715N/ACompleted
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Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)

Stanford University·interventional·Posted Mar 3, 2017·Updated May 18, 2022

In Brief

A clinical study evaluating Active TBS-DLPFC, Sham TBS-DLPFC, and 1 other intervention for Treatment Resistant Depression. Completed, enrolled 30 participants across 1 site.

Detailed 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 fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 3, 2017
Enrollment StartMar 20, 2017
Primary CompletionJan 25, 2020
Study CompletionJan 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.3 years ago

Interventions

Active TBS-DLPFCdevice

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 stimulator.

Sham TBS-DLPFCdevice

The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.

Open label TBS-DLPFCdevice

All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase. Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device.