BRIGhTMIND Version 1.0
Research type
Research Study
Full title
Randomised double-blind controlled trial of connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment resistant moderate to severe depression evaluation of efficacy, cost effectiveness and mechanism of action
IRAS ID
245025
Contact name
Richard Morriss
Contact email
Sponsor organisation
Nottinghamshire Healthcare NHS Foundation Trust
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
The study is testing the effectiveness of a new approach to treat treatment resistant depression (TRD) using pulses of magnetic stimulation applied to the scalp. Treatment resistant depression is depression that has not improved with at least two previous antidepressant treatments.The treatment that is being tested is called Transcranial Magnetic Stimulation (TMS) and has been recommended for use in the NHS in the UK by the National Institute for Care Excellence (NICE) as a treatment for treatment resistant depression.There are uncertainties about how to achieve the best results from this procedure, in terms of where it needs to be targeted on the scalp and compare the pattern of the magnetic pulses. Recent developments in magnetic resonance brain imaging means that a part of the brain can be located in each person where three different brain systems involved in producing depression symptoms meet. Targeting the magnetic pulses at this site, which varies slightly in its position in each person, can be assessed to see if proportion of people who respond to TMS and the length of time they remain well afterwards might be increased. If so then it may be worth people having these brain scans before receiving TMS. People over the age of 18 years with a diagnosis of moderate to severe depressions that is Treatment resistance are eligible to take part. The study will last for 45 months with participant involvement will end after 39 months. Patients will be assessed for eligibility and asked to attend a baseline appointment. If still eligible they will attend MRI Brian scan they will be randomised to one of two treatment groups and asked to attend 20 treatment sessions over 4-6 weeks. They will be followed up at 8,16 and 26 weeks with another MRI scan at 16 weeks.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0232
Date of REC Opinion
30 Aug 2018
REC opinion
Further Information Favourable Opinion