Clinical Utility of ZATMM in ADHD
Research type
Research Study
Full title
A Clinical Study of Zip and the Misty Mountain to measure Efficacy and Incremental Clinical Utility of Reducing Symptoms of Attention-Deficit/Hyperactivity Disorder
IRAS ID
272952
Contact name
Serena Haywood
Contact email
Sponsor organisation
Cortechs
Duration of Study in the UK
0 years, 10 months, 23 days
Research summary
This is a non-blinded, single-centre randomized control study. The study seeks to establish efficacy and incremental clinical utility of Zip and the Misty Mountain Mobile Software and the, already CE marked, Myndplay Headband in a sample of children aged 6-12 years of age with ADHD receiving pharmacological treatment.
The investigational product is a game loaded onto a tablet to be used in conjunction with a non-invasive brainwave sensing (EEG) headset. Games contain both cognitive and neurofeedback training to improve attention deficit behaviours. Neurofeedback used alongside standard treatment has been linked to decreased ADHD symptoms. Anticipated benefits to the patient population include improved attention level and longer term improved academic, schoolwork, social interactions/skillsets and secondary behaviours.
Potential subjects will be identified and approached at the PI’s regular clinic. The PI may also contact potential participants by phone. Advertising materials will be displayed in the clinic and with a patient advocacy group. Once eligibility is determined, subjects will be randomly assigned to one of two groups: Waitlist/Treatment-As-Usual; and Intervention. Participants will continue adhering to their ADHD medication regimen as well as scheduled clinician visits and standard community treatments.
Subjects assigned to the Intervention Arm will participate in 24 individual 20-minute game playing sessions occuring 3 times a week over 8 weeks. All subjects will be evaluated by Performance Based Testing (Stroop Evaluations) and Parent Assessment (Conners-3 and BRIEF-2) at Baseline and week 8. These may be repeated at 32 weeks, this visit may be implemented by the Sponsor after review of initial data from a defined number of subjects.The study is planned to take place in one study site and has been organised and funded by Cortechs who own the Zip and the Misty Mountain Software. Some funding also received from the European Commission.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0329
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion