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tDCS depression treatment - Flow Neuroscience
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Instructions for FLOW NEUROSCIENCE models including: Flow Headset Medically Approved Brain Stimulation, Medically Approved Brain Stimulation, Approved Brain Stimulation, Brain Stimulation, Stimulation
28 nov 2024 — Mechanism of action. The Flow headset delivers a gentle 2mA electric current (transcranial. Direct Current Stimulation, tDCS) to the left dorsolateral ...
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DocumentDocumentFlow Clinician Overview Treat Depression. Differently. Indication Class IIa medical device approved for the treatment of unipolar major depressive disorder (MDD) in adults, either as monotherapy or as an adjunct with antidepressants and psychological therapies. Mechanism of 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. Efficacy Results at 10 weeks from a multisite, double-blind placebo-controlled randomised superiority trial were statistically significant for both primary and secondary endpoints. Flow achieved a 57.5% remission rate using the MADRS scale and was effective as both standalone and adjunctive therapy.1 Remission rate when used as standalone and adjunct: 67.1% Flow tDCS + Antidepressants 42.9% Sham tDCS + Antidepressants 48.6% Flow tDCS alone n=56 p=0.037 n=53 n=31 p=0.005 11.3% Sham tDCS alone n=33 Open-label patient cohort study in an NHS primary care general practice found at 6 weeks: 2 · 58.1% of patients showed reliable improvement, and 32.3% achieved remission using the PHQ-9 · Significant improvements were observed in functioning (WSAS) and health-related quality of life (EQ-5D-5L) Improvements in Depression Severity and Functional Impairment 16 Baseline score 8.48 Post-intervention score 20.43 Baseline score 11.8 Post-intervention score PHQ-9 WSAS 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. Activation Phase Weeks 1-3 · Includes 5 stimulations a week · Introduces optional behavioral therapy courses via the app Strengthening Phase: Week 4 onwards · Includes up to 2 stimulations a week · Continues to strengthen and preserve results · Continue behavioural therapy courses Behavioural therapy 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 absolute 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) Special populations Other chronic conditions: No known interactions with medications; used by individuals with diabetes, heart disease, hypertension, asthma, cooccurring 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+ Adverse reactions Based on real world evidence from >20,000 users, the incidence rate of adverse reactions is 4.5%, which is favourable against antidepressants. Side effect Incidence Probable duration Recommendations to reduce intensity and/or duration Skin irritation (including tingling, stinging redness 10% to < 20% Less than a day. Rarer cases up to 3 days Avoid stimulating on irritated skin · new pads with each stimulation · well-moisturised skin · well-hydrated · ice pack following stimulation · correct electrode placement Headaches 10% to < 20% Less than a day Adequate hydration · relaxed environment · correct electrode and headset placement · post-stimulation rest Worsening depression symptoms and/ or anxiety 1% to < 10% Up to several days. Usually only occurs in the first few weeks of treatment Relaxed environment · correct electrode placement Fatigue, malaise and sleep 1% to < 10% disturbances Up to several days Changing/fixing time of day of stimulation · relaxed environment Tinnitus 0.1% to < 1% Less than a day. In rare cases persisting for a few weeks Correct electrode placement · monitoring during session and stop use if persisting 1st degree skin burns 0.1% to < 1% Up to 3 days New pads with each session · avoid stimulating on irritated skin · well-moisturised skin · well-hydrated Photopsia (Flashes of Light) 0.1% to < 1% Up to a minute Ensuring correct electrode contact and placement · not removing headset without powering down Hypomania/ Mania < 0.01% Up to several days Closer monitoring if history of bipolar disorder Adverse events should be reported. Report forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Flow Neuroscience by emailing support@flowneuroscience.com. Clinician review and customisation Review your patients' progress and adherence through the Flow Clinician Platform (CPP). Accessible anytime and anywhere through a secure web browser, this platform streamlines patient visits by providing informed insights. It also allows for the customisation of treatment protocols (maximum 1 per day, 7 per week) based on clinical judgement to address individual patient needs. This setup ensures personalised treatment adjustments to help optimise patient outcomes. Support and contact Information For technical support and assistance, patients can contact support@ flowneuroscience.com. Clinicians can enquire about setup, pricing, and training support by contacting clinical@flowneuroscience.com. The suggested initial treatment duration is 10 weeks. Following 10 weeks, patients' response should be assessed and length of continued treatment determined, taking into consideration the effectiveness to date and the risk of relapse. Person has completed 10 week course of Flow Higher risk of relapse if: · History of recurrent episodes and/or incomplete response previously · History of severe depression · Coexisting physical or mental health problems · Unhelpful coping styles (such as avoidance, rumination) · Personal, social or environmental factors that are contributing to depression Has full or partial response Yes been achieved? No Is the person at higher risk Yes of relapse? No Continue strengthening phase for at least 12 months Consider other treatments +/restarting activation phase Continue strengthening phase for at least 6 months www.flowneuroscience.com References: 1. Woodham, R.D., Selvaraj, S., Lajmi, N. et al. Nat Med (2024). 2. Griffiths, C. et al. (2024). Open Journal of Depression. 13(02), 2539. Class IIa medical device CE 673331 UKCA 776047 Holder: Flow Neuroscience AB, Södra Tullgatan 3, 21140 Malmö www.flowneuroscience.com