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Trial record 5 of 5 for:    tdcs | Depression | United Kingdom

Empower: tDCS for Major Depressive Disorder at Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05202119
Recruitment Status : Completed
First Posted : January 21, 2022
Last Update Posted : November 28, 2023
University of Texas
University of East London
Information provided by (Responsible Party):
Flow Neuroscience AB

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial direct current stimulation Device: Sham Transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Participants and investigators are unaware of what stimulation (active or sham) the device delivers.
Primary Purpose: Treatment
Official Title: Empower: Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Superiority Trial
Actual Study Start Date : May 1, 2022
Actual Primary Completion Date : June 6, 2023
Actual Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Active stimulation
Active stimulation at 2mA
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.

Sham Comparator: Sham stimulation 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.

Primary Outcome Measures :
  1. HDRS-17 [ Time Frame: 10 weeks ]
    Mean score change based on HDRS-17 scores of the two arms at 10 weeks compared to baseline.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • Subject agrees to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study.
  • Subject agrees to a Safety/Suicide Risk Management Protocol, which is intended to reduce the reduce the risk of suicide during study participation.

Exclusion Criteria:

  • 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.
  • Are currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria.
  • 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).
  • Have a cognitive impairment (including dementia).
  • Have a history of mania or psychosis.
  • Are currently using any medications that affect cortical excitability (e.g., benzodiazepines, epileptics, etc.).
  • Are currently experiencing symptoms of withdrawal from alcohol or benzodiazepines.
  • Have been diagnosed with Parkinsonism or other movement disorder as determined by the investigator to interfere with treatment.
  • Have ever taken esketamine / ketamine for treatment of depression.
  • Have ever been admitted to hospital for depression.
  • Have been diagnosed with obsessive-compulsive disorder (OCD), bipolar type 1 or 2 disorder, an active primary anxiety disorder, PTSD, agoraphobia, panic or personality disorder.
  • Have a history of psychosurgery for depression.
  • Have any history of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.
  • Are currently experiencing or have a history of intractable migraines.
  • Are a chronic tobacco smoker, as defined by smoking >100 cigarettes (including hand-rolled cigarettes, cigars, cigarillos, etc.) in their lifetime and has smoked every day in the last 7 days.
  • If female and of child-bearing potential, currently pregnant or breastfeeding or planning to become pregnant or breastfeed any time during the study.
  • Are currently a prisoner.
  • Are participating concurrently in another clinical investigation or have participated in a clinical investigation within the last 90 days or intend to participate in another clinical investigation during the study.
  • Have any medical condition or other circumstances, in the judgment of the investigator, that might interfere with the ability to complete follow-up visits and the self-reported MADRS-s in the app.
  • Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance.

Information from the National Library of Medicine

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 identifier (NCT number): NCT05202119

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United States, Texas
UT Health Science Center
Houston, Texas, United States, 77030
United Kingdom
School of Psychology, University East London
London, United Kingdom, E16 2RD
Sponsors and Collaborators
Flow Neuroscience AB
University of Texas
University of East London
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Responsible Party: Flow Neuroscience AB Identifier: NCT05202119    
Other Study ID Numbers: FL001
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Flow Neuroscience AB:
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms