A headset, which appeared in a banned advert by reality TV star Gemma Collins, can help stop depressed patients making attempts on their own life, according to an NHS trial.
Flow, a pulsating headset that claims to treat depression by sending electric shocks to parts of the brain responsible for regulating mood, reduced the incidence of suicidal thoughts by 75 per cent in a group of 83 patients.
The hospital trust trialling the device noted a significant reduction in self-harm related hospital admissions.
What’s more, a third of the patients who used the device for six months were said to be in remission from depression, the study authors, from Leicestershire Partnership NHS Trust reported.
The ad, which was posted in May last year, drew the ire of the Advertising Standards Agency (ASA) which said the post violated rules designed to stop ads from discouraging people from seeking treatment for medical conditions
Leicestershire Partnership NHS Trust offered the Flow depression treatment via its crisis service — which supports NHS patients at immediate risk of harming themselves or who are unable to cope with day-to-day life due to an acute mental health issue.
The six-month long trial found the wearable device helped patients stabilise quickly with positive changes in mood showing within two to three weeks of treatment.
The makers of the Flow headset, which is available to buy from high street chemists, costing £399, describe it as a ‘brain stimulation wearable’ that leverages a technology known as transcranial direct stimulation (tDCS).
In tDCS, small electrical currents (less than a household battery) are transmitted to the prefrontal cortex, which regulates emotions.
Over time, the stimulation causes neurons to fire more frequently, strengthening the neural pathways in the prefrontal cortex.
According to the company, clinical studies have proved that patients with depression have lower activity in this area of the brain.
The headset is supported by an app which lets users log their perceived benefits, which can be remotely monitored by a clinician.
According to the company, clinical studies have proved that patients with depression have lower activity in this area of the brain, which is the part of the brain responsible for cognitive tasks and regulation of emotion
Crisis services provide rapid care and prevent escalation of mental health crises.
Where possible, the goal is to safely enable the patient to receive treatment at home rather than in hospital.
In the new trial, many patients who did not reach remission still saw a marked reduction in depressive symptoms after using the device for six months, with many downgraded from severe depression to moderate or mild.
Dr Mark McConnochie, Consultant Psychiatrist and Clinical Director for Urgent Care Services at Leicestershire Partnership NHS Trust said: ‘Flow has been an amazing tool to safely and effectively help patients with depression to recover faster.
‘The feedback from our patients and staff has been overwhelmingly positive, and the results from this trial are making a real difference to the lives of the people of Leicester, Leicestershire and Rutland.’
Suicide rates and self-harm events are rising and experts are calling for new approaches for treating depression.
UK-wide NHS data shows that the demand for mental health crisis services has doubled since 2017 and increased by around a third since before the pandemic.
More than 90,000 people are referred to community crisis services monthly, and 200,000 people call the NHS 24/7 crisis line each month.
The Flow headset, which doesn’t need a prescription, is described as a ‘ brain stimulation wearable that leverages transcranial direct stimulation (tDCS) to activate the left dorsolateral prefrontal cortex’, parts of the brain responsible for mood regulation
Support for depression can often be complicated as no single treatment works for all.
Out of the approximately one in three people who went into remission or response after using Flow, 59 per cent of the patient group had indicated that they’d already tried antidepressants and therapy.
This suggests the device could be used on patients who are not responding to other treatments.
Dr Sherif Abdalla, Consultant Psychiatrist CRHT at Leicestershire Partnership NHS Trust said: ‘It is wonderful to be witnessing from close a huge jump in the quality of treatment of Depression and Suicidal patients, that can change our treatment guidelines soon.
‘Thanks to Flow, patients are back to their normal lives in a very short time with no concern of side effects’.
The treatment is already accessible via five other NHS services for the management of depression.
The data validates results already seen in smaller NHS studies, recognising the headset as a safe, effective treatment for depression.
However, an advertisement of the device has previously come under fire.
In May last year Gemma Collins, who has 2.2million Instagram followers, was ordered by the Advertising Standards Authority (ASA) to remove an advert for the device posted to her Instagram page.
The reality star claimed in the video she had stopped taking antidepressants and said the device had been a ‘real game changer’.
She added: ‘Flow actually works faster and better than antidepressants.’
The post violated the ASA rules designed to stop ads discouraging people from seeking treatment for medical conditions.
The ASA highlighted NHS advice stating it is not recommended for people with depression to stop taking medication for their condition without supervision.
In 2021, NHS watchdog NICE updated its guidance for the psychiatric medication — taken by an estimated 8.6 million Brits — stating that patients should be tapered off the drugs as going cold turkey could result in withdrawal symptoms.
Doctors’ guidance advises that patients should be monitored while coming off antidepressants in case they suffer a mental health crisis.
The ASA concluded its ruling by stating the ad discouraged ‘essential treatment’ for a medical condition and therefore breached the code.
Although the initial NHS trial has come to an end due to its success researchers are interested in expanding the use of the depression treatment.
Flow Neuroscience CEO Erin Lee said: ‘The Leicestershire results are very promising and further add to our existing studies which demonstrate compelling evidence that Flow is an effective depression treatment.
‘Depression is a very complex condition, and having more options available to patients is vital.
‘With suicide rates increasing rapidly, effective and accessible solutions that can be integrated into the healthcare system must be made available to help address the number of people suffering from the devastating consequences of today’s mental health crisis.’
