Empower: tDCS for Major Depressive Disorder at Home

NCT05202119 | Completed Results FDA Device

• 1 other identifier: FL001
• Study Type: interventional
• Target: 174
• Locations: 2 countries
• Sites: 2

Brief 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

Major Depressive Disorder

Keywords

tDCS

Outcome Measures

Primary Outcomes (1)

• HDRS-17 - Hamilton Depression Ratin Scale

  Comparison of mean score change based on HDRS-17 scores of the two arms at 10 weeks. Mean score change is calculated as change in score from baseline to week 10. HDRS-17 is a clinician rated diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Range of scores: 0 to 52. Higher scores represent greater severity of depressive symptoms.

  10 weeks

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Active stimulation at 2mA

Device: Transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

Device: Sham Transcranial direct current stimulation

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.

Active stimulation

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.

Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥18 years.
• Have a diagnosis of Unipolar MDD with a current depressive episode as defined by the diagnostic criteria in the Diagnostic and statistical manual of mental disorders - 5th edition (DSM-V)
• Have a Hamilton Depression Rating Score (HDRS-17) of ≥ 16.
• Have PHQ-9 of ≥10.Montgomery-Åsberg Depression Rating Scale Self-Report (MADRS-s) of ≥ 20.
• For 6 weeks prior to enrollment, are either: not taking antidepressant medication or:
• are taking a stable antidepressant regimen with a stable medication source and agree to continue the same regimen throughout study participation
• If in psychotherapy, have maintained stable psychotherapy for at least 6 weeks prior to enrollment.
• Have access to a stable internet connection through which the treatment will be received.
• Have access to a smartphone or other device running Android 5.0+ or iPhone Operating System (iOS) 12+ (e.g., reasonably new iPhone/iPad or Android phone), used to using the device in their everyday life, and can capably use the study application on the device, as determined by the investigator.
• Are currently living in England/Wales (UK) or Texas (US).
• Subject is currently under the care of a psychiatrist or a primary care physician, agrees to be evaluated at regular intervals by a psychiatrist or primary care physician for the duration of study participation, and agrees to promptly inform the study staff of any change of psychiatric or mental health providers during study participation.
• Subject agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment.
• Subject agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons ≥ age 18 (22 in the US) who reside within a 60-minute drive of the patient's residence and whom the research staff is at liberty to contact, as they deem necessary, for the duration of study participation.
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
• Be willing and able to comply with all study procedures.

You may not qualify if:

• Are in a current state of mania, as determined by the YMRS or psychosis, as determined by the MINI.
• Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
• Considered to have treatment resistant depression as defined by inadequate clinical response to 2 or more trials of antidepressants at an adequate dose and duration.
• Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.
• Patient answers Yes to Questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Triage and Risk Identification Screener.
• Any previous hospitilization for suicidal behavior.
• Have chronic or current severe insomnia (\< 4 hours of sleep each night), or sleep apnea.
• Have any structural lesion (e.g., any structural neurological condition, or more subcortical lesions than would be expected for age or have had a stroke that affects stimulated area or connected areas) or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results, as determined by the investigator.
• Have any implant in the brain (e.g., DBS) or neurocranium, or any other active implantable medical device.
• Have any neurocranial defect.
• Have a history of epilepsy or seizures (including history of withdrawal / provoked seizures).
• Have shrapnel or any ferromagnetic material in the head.
• Have any disorder that would impair the ability to complete the study questionnaires.
• Have been diagnosed with autism spectrum disorder.
• Are actively abusing substances (\<1 week prior to enrollment).

Sponsors & Collaborators

• Flow Neuroscience AB: lead
• University of Texas: collaborator
• University of East London: collaborator

Study Sites (2)

UT Health Science Center

Houston, Texas, 77030, United States

Location

School of Psychology, University East London

London, London, E16 2RD, United Kingdom

Location

Related Publications (2)

• Lagerberg PJ, Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Rizvi M, Kwon SS, Orhii P, Machado-Vieira R, Soares JC, Young AH, Fidalgo AR, Rezaei H, Fu CHY. Acceptability of active and sham home-based transcranial direct current stimulation in major depression: mixed methods qualitative analysis in a randomised controlled trial. Ann Gen Psychiatry. 2025 Dec 4;25(1):1. doi: 10.1186/s12991-025-00607-4.

  PMID: 41345653 DERIVED

• Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21.

  PMID: 39433921 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Cynthia Fu
• Organization: King's College London

cynthia.fu@kcl.ac.uk

020 8223 4119

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and investigators are unaware of what stimulation (active or sham) the device delivers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 21, 2022
• Study Start: May 12, 2022
• Primary Completion: June 6, 2023
• Study Completion: August 31, 2023
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Locations

GB (1); US (1)