Development and Validation of the TRIAL® database for Rett Syndrome
Research type
Research Study
Full title
Development and Validation of the TRIAL® (Tailored Rett Intervention and Assessment Longitudinal) database for Rett Syndrome
IRAS ID
179671
Contact name
Paramala Santosh
Contact email
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Rett Syndrome (RTT), a pervasive neurological disorder, is characterized by compromised brain functions, severe mental retardation, language and learning disabilities, repetitive stereotyped hand movements and developmental regression. As far as we are aware, no complete all-embracing instrument has been developed for patients with RTT that has the ability to capture longitudinal pharmacological, behavioural and genetic information and be able to correlate this with the physiological aspects of the disease. At present there are no datasets or instruments that provide such information. Previous datasets/instruments have been inconsistent and provide little information on the behavioural and physiological facets of the disease. The aim of this study is to develop and validate a clinically meaningful new questionnaire with a view to construct an all-encompassing instrument which can provide pharmacological, behavioural, and genetic data, and which can then be correlated with the physiological information captured using a wristband device. The study will consist of three parts: (1) Questionnaire development, (2) Questionnaire validation and (3) wearable technology E4/Embrace stage.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1772
Date of REC Opinion
30 Oct 2015
REC opinion
Favourable Opinion