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SAINT for Treatment of Preoperative Depression to Reduce Opioid Use Following Arthroplasty

NCT04195308 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-14

No results posted yet for this study

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.

Conditions

Interventions

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 stimulator.

DEVICE

Sham TBS-DLPFC

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.

DEVICE

Open label TBS-DLPFC

Patients will have the option of receiving active, open label aTBS treatment following sham. Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device.

Sponsors & Collaborators

Principal Investigators

  • Nolan Williams, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04195308 on ClinicalTrials.gov