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Empower: tDCS for Major Depressive Disorder at Home

NCT05202119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-04-22

Study results available
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Summary

A two-center trial to investigate whether or not active stimulation with the Flow FL-100 tDCS device is superior to sham stimulation for the treatment of major depressive disorder when used at home.

Participants perform up to 36 tDCS sessions by themselves without supervision during a blinded 10-week phase, and then 30 more sessions during an unblinded open-label phase.

Conditions

Interventions

DEVICE

Transcranial direct current stimulation

Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.

DEVICE

Sham Transcranial direct current stimulation

To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • University of East London

    collaborator OTHER

  • Flow Neuroscience AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2023-06-06
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States
  • United Kingdom

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 NCT05202119 on ClinicalTrials.gov