Empower: tDCS for Major Depressive Disorder at Home

Part of paid clinical trials in Houston, Texas.

Sponsor
Flow Neuroscience AB
Study ID
NCT05202119
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial direct current stimulation — DEVICE
    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.
  • Sham Transcranial direct current stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 12, 2022
Status verified
Apr 2026
Primary completion
Jun 6, 2023
Completion
Aug 31, 2023

Study Design

Enrollment
174 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active stimulation
    Active stimulation at 2mA
  • Sham Comparator: Sham stimulation

Primary Outcome Measure

HDRS-17 - Hamilton Depression Ratin Scale [ Time Frame: 10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Health Science CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
UT Health Science Center· Houston, TX

Related Studies