OptiCALS RCT

Study titleOptiCALS RCT
UK Chief InvestigatorProf Christopher McDermott
Research summaryA Randomised Controlled Trial with parallel Process Evaluation and Health Economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with Amyotrophic Lateral Sclerosis
Inclusion/exclusion criteriaINCLUSION CRITERIA

Age 18 years or older.

Diagnosis of clinically definite, lab supported, clinically probable, or possible ALS by the El-Escorial criteria and additionally the PMA variant where appropriate investigation has excluded mimics of motor neuron disease.
Within 2 years of onset of first muscle weakness.
Stabilised on Riluzole for one month or not on Riluzole.

EXCLUSION CRITERIA

Co-morbidity that would affect survival or metabolic state (e.g. unstable thyroid disease or unstable diabetes mellitus). - BMI > = 35kg/m2.
Lacking capacity to provide fully informed written consent, verbal consent (for those who cannot provide written consent), or consent via the use of a communication aid.
Previous participation in the HighCALS PGfAR research programme.
Unable to understand written and spoken English.
Using a gastrostomy tube for feeding (those using a gastrostomy tube for fluid or medication are not excluded).
Current statusActive – recruiting
LocationsThe Walton Centre for Neurology and Neurosurgery
John Radcliffe Hospital, Oxford
Royal Hallamshire Hospital, Sheffield
Ninewells Hospital, Dundee
Contact details
Recruitment group(s)Participant groups:
1. Patients with MND
2. Family members of patients with MND (including pre-symptomatic gene carriers)
3. Healthcare Professionals
Recruitment target(s)The maximum targets are:
We aim to recruit 304 participants, with 152 participants in the control group and 152 participants in the intervention group. Regarding professionals, we hope to recruit 30, (10 PIs and 20 interventionists). We don't have a concrete target for carer recruitment as a proportion of the patient participants will also have their carer recruited, but this is optional for them. Some will not have carers and some carers may not want to participate. So excluding carers, the total sample size should be 334.
Key datesActual opening date: 10 August 2021
Recruitment planned end date: TBC
Funder(s)National Institute of Health Research Central Commissioning Facility
Programme Grants for Applied Research
SponsorUniversity of Sheffield
Study design
Intervention (if applicable)
Phase (if applicable)Phase 4
Outcome measures
Publications / Results reportsLinks will be provided when papers are published.
Participant Information Sheet