FLOW | CXDX

FLOW NeuroScience (ARTG # 509725)

What is FLOW?

Flow is a depression treatment that consists of a tDCS headset and behavioural therapy app
programme. The treatment targets various root causes of depression.

The Flow tDCS is a Class IIa medical device approved for the treatment of major depressive disorder (MDD) in adults, either as monotherapy or as an adjunctive treatment. The device is accessible to patients under the supervision of an appropriately qualified health practitioner and able to be ordered through the Patient Purchase Portal on Aurora Direct.

It is important to always use Flow in accordance with the Flow Neuroscience User Manual.

What is tDCS?

tDCS stands for transcranial direct current stimulation (tDCS). Which is a pain-free and noninvasivebrain stimulation technique. This technique uses gentle electrical currents torestore brain activity and reduce depressive symptoms.The Flow tDCS headset reinforces naturally occurring brain signalling in the DorsolateralPrefrontal Cortex (also known as the DLPFC). This area of the brain is targeted as it has beenshown to be less active when depressed. The Flow headset delivers a weak current (2 mA) tothis brain region via electrodes placed on the forehead. Since Flow can directly target theDLPFC, side effects are less common and less severe than those from antidepressants.

How does the process work?

Flow is designed to optimise outcomes for both patients and clinicians by offering tailored solutions for each. Patients are equipped with the Flow tDCS Headset and companion app, allowing them to conveniently manage their treatment from home. Clinicians benefit from a remote monitoring platform that provides real-time insights into patient adherence, outcomes, and supports data-driven care decisions. Clinicians can adjust and customise patient stimulation schedules according to clinical need*.

*Subject to clinical qualifications and training

Download the Clinician Overview

Why FLOW?

The recent EMPOWER clinical trial results, published in Nature Medicine, demonstrate Flow is effective and superior to the sham treatment1. This 10-week double-blind placebo-controlled randomised study reviewed the use of Flow compared to placebo across 173 adult participants diagnosed with unipolar depression (moderate to severe).

Real-world data2 and various ongoing pilots3 show similar results. The EMPOWER trial also highlighted a potential amplification when Flow was used in combination with an antidepressant. This impact has also been reported in real-world cases.

Key question - Could Flow be of interest to your patients looking for depression relief?

*Remission defined as a score of ≤12 on MADRS

Read the Nature Medicine article

Who is right for FLOW?

FLOW is approved for use in anyone 18 or older with a Major Depressive Disorder (MDD) disorder, either as monotherapy or as an adjunctive treatment. The device is only to be used under the supervision of an appropriately qualified health practitioner (you will need to download the Medical Authorisation and Consent Form as part of the order process).

FLOW has been provided to patients across Primary Care, Perinatal Services, Crisis Services and Community Mental Health settings internationally.

Medical Authorisation and Consent Form

What is the mechanism of device action?

The Flow headset delivers a gentle 2mA electric current (transcranial Direct Current Stimulation, tDCS) to the left dorsolateral prefrontal cortex. This region is crucial for emotional regulation and is often hypoactive in individuals with depression. tDCS enhances neuronal activity in this area, counteracting hypoactivity, improving mood and emotional regulation.

How can I monitor patient progress?

Effortlessly review your patients’ adherence and progress with Flow’s Clinician Platform. Accessible anytime, anywhere through a secure web browser, this platform aggregates data including weekly MADRS-s scores and daily stimulation tracking. With these insights, you can monitor patient response, ensure treatment adherence, and easily customise individual treatment schedules to help optimise patient outcomes.

What is the FLOW treatment schedule?

The standard treatment is split into 2 phases – activation and strengthening. Each session (termed stimulation) is 30 minutes long. Patients complete a MADRS-s survey at the beginning of each week to monitor progress.

Behavioural Therapy, Contradindications, Warnings and Precautions

The Flow app includes 7 behavioural therapy courses including behavioural activation, exercise, meditation, diet, and sleep hygiene, totalling over 50 short therapy sessions. These courses are entirely optional and do not interfere with the Flow stimulation protocol.

Contraindications - No universal contraindications.

Warnings and Precautions

Broken/inflamed/infected skin (including, for example, psoriasis) at the electrode site
Cranial or intracranial implant (e.g. brain clips, deep brain stimulators)
Craniofacial abnormalities (e.g., congenital deformities, severe trauma, or reconstructive surgeries) which may aﬀect electrode placement
Epilepsy or history of seizures
Active suicidal ideation (requires closer monitoring)
History of hypomania or mania (may require closer monitoring)

For additional information around warnings and precautions please refer to User Manual.

Special populations

Other chronic conditions: No known interactions with medications; used by individuals with diabetes, heart disease, hypertension, asthma, co- occurring mental health conditions, neurodivergence, and brain injuries/ disorders without reported safety concerns.
Pregnancy: Not licensed for use; no safety concerns identified in existing studies, research ongoing.
Breastfeeding: Safe to use; no eﬀect on breast milk production.
Postpartum: Appears safe for postpartum depression and successfully used in NHS pilots.
Children and Adolescents: Not licensed for use; studies ongoing for ages 14+