Dystonia grading scales study
Research type
Research Study
Full title
Prospective observational study to assess the validity of the functional disability score (FDS) in patients with blepharospasm, hemifacial spasm and synkinesis treated with botulinum toxin (BT) injection.
IRAS ID
297057
Contact name
Linda Okafor
Contact email
Sponsor organisation
Queen Victoria Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
297057, IRAS NUMBER
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Essential blepharospasm (EB), hemifacial spasm (HFS) and aberrant regeneration of the facial nerve (AFR) are all movement disorders treated with botulinum toxin. Botulinum toxin (BoNT) was first approved for medical use on extraocular muscles to treat non-accommodative strabismus and, subsequently, efficacy was demonstrated in EB, HFS and AFR.
A number of different measurement tools and scales have been used to evaluate the effects of BoNT on various aspects of blepharospasm, including force of eyelid closure, severity of muscle spasms and patient functional status. Today the rating instruments have coalesced into several main clinical scales including the Jankovic Rating Scale (JRS) and the Blepharospasm Disability Index (BSDI).
Instruments that assess activities of daily living or patient functional status are rated by the patients themselves. These scales recognise the importance of improvement in activities of daily living as an outcome of therapy. Whilst the validity of the BSDI is well documented to date the FDS has not been fully validated by any other centre apart from the original describer.
The principle aim of this study is to repeat validation of the FDS against the BSDI which has been validated by several groups since its original description. In particular we aim to compare the rating scales with respect to their metric properties in patients with EB, HFS and AFR. The metric properties of the scales, with special regard to their usefulness for assessment of treatment efficacy, include evaluating the internal consistency (as an aspect of reliability), convergent validity and equivalence in comparison to the other scales and sensitivity to change with treatment as another aspect of validity.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0072
Date of REC Opinion
3 Jun 2021
REC opinion
Further Information Favourable Opinion