Biomarkers of Response to Treatment With Frontal Cortex Stimulation for Anxious Depression
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|ClinicalTrials.gov Identifier: NCT03999736|
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Anxiety||Device: transcranial direct current stimulation using a Soterix mini-CT device||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label|
|Masking:||None (Open Label)|
|Official Title:||Biomarkers of Response to Treatment With Frontal Cortex Stimulation for Anxious Depression|
|Estimated Study Start Date :||November 3, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
14 sessions x 30 minutes of 2mA transcranial direct current stimulation to the dorsolateral prefrontal cortex.
10 x sessions over the course of the initial two weeks (e.g. 5 x per week with flexibility).
4 x sessions over the course of a two week maintenance treatment.
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.
Other Name: tDCS
- Number of participants with a reduction in depressive symptoms of 50% or more [ Time Frame: 4 weeks after first stimulation session ]The Montgomery-Asberg Depression Rating Scale will be used as a measure of depressive symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999736
|Contact: Maria A Ironside, DPhil||617 417 email@example.com|
|Contact: Diego A Pizzagalli, PhD||617 855 firstname.lastname@example.org|
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|