Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)
NCT05205915 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2022-10-05
Summary
This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.
Conditions
Interventions
- DEVICE
-
tDCS intervention applied by Starstim device
Stimulation will be applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents). The montage has been designed to optimize anodal stimulation in the desired target area while avoiding stimulation off target.
Sponsors & Collaborators
-
Neuroelectrics Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-02
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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