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Biomarkers of Response to Treatment With Frontal Cortex Stimulation for Anxious Depression

NCT03999736 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-02-12

No results posted yet for this study

Summary

This is an add-on study to an existing multimodal neuroimaging study in MDD by investigating the acute effects of DLPFC tDCS on threat vigilance in 24-44 patients with MDD, as part of an open-label treatment intervention study. Behavioral and neural measures of threat vigilance will be taken acutely and investigated as predictors of subsequent treatment response to a four-week, fourteen-session DLPFC tDCS intervention, using a novel home-tDCS protocol. The design takes advantage of an existing rich set of candidate baseline behavioral, neural and molecular measures from the existing neuroimaging study, which could be used to predict treatment response to tDCS and thereby, aid future patient selection for clinical trials.

Conditions

Interventions

DEVICE

transcranial direct current stimulation using a Soterix mini-CT device

TDCS is used to non-invasively stimulate the brain through the application of electrical currents to a small region of the scalp using a battery-powered stimulator (Soterix Medical 2018) with rubber electrodes and conductive material (saline-soaked sponges). Both electrodes are attached to the scalp with a band. The stimulation points will be located using the 10-20 system of electroencephalogram (EEG) electrode location (localization carried out using a bespoke head strap). The electrode size of the stimulator used in this study is large (25 cm2) and the current strength used is low (2 mA) resulting in very low current density (0.08 mA/cm2). This protocol applies no more than 30 minutes of stimulation in a single session, which is typical for experimental studies (Brunoni et al. 2015; Loo et al. 2017). TDCS is an investigational device and has proceeded with a non-significant risk designation in many past trials and not required an investigational device exemption from the FDA.

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2021-02-09
Completion
2021-02-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03999736 on ClinicalTrials.gov