Alpha Stim-D
Research type
Research Study
Full title
Randomised controlled trial of the clinical and cost effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in treatment seeking patients with moderate severity depressive episodes in primary care.
IRAS ID
276646
Contact name
Richard Morriss
Contact email
Sponsor organisation
Research and Innovation
ISRCTN Number
ISRCTN11853110
Duration of Study in the UK
2 years, 6 months, 13 days
Research summary
Why is the research needed?
Depression affects one person in every six in a year. Many people with depression do not find anti-depressant medication or talking therapies to be helpful, acceptable or easy to access so they do not seek help with their depression. Alpha-Stim AID is a clinically proven battery operated medical device that provides cranial electrotherapy stimulations (CES) to treat anxiety, insomnia and depression. The device changes the electrical activity of the brain from more stressful delta and beta rhythms to more relaxing alpha rhythms.What is already known about the topic?
Research shows Alpha-Stim AID improves anxiety and depression symptoms in people with anxiety disorders. It is safe and has few side effects. It is licensed to be sold directly to the public at a cost of approximately £500.What we will do?
We will ask 230 patients with depression attending their GP surgery who have moderate depression to take part. By a process like tossing a coin, people with depression will either be allocated to use an active Alpha-Stim AID device or a device that looks exactly the same but does not emit a current. The current is so small it is impossible to tell if it is the active device or not. Participants will be asked to use the devices every day for one hour for eight weeks. We will measure any change in depressive and anxiety symptoms and change in healthcare service use.These assessments will be at the beginning if they have agreed to take par, 4, 8 and 16 weeks later. We will also ask people their thoughts on using the device and record their use of the device and any side effects.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0061
Date of REC Opinion
25 Mar 2020
REC opinion
Further Information Favourable Opinion