SHAPED-TF
Research type
Research Study
Full title
Study of HAllucinations in Parkinson’s disease, Eye disease and Dementia – Trial Feasibility
IRAS ID
224419
Contact name
Keith Brennan
Contact email
Sponsor organisation
Institute of Psychiatry, Psychology and Neuroscience, King's College London,
Duration of Study in the UK
0 years, 9 months, 17 days
Research summary
An estimated 2 million people in the UK have visual hallucinations, most in the context of dementia, eye disease and Parkinson’s disease. The symptoms cause significant distress for patients and their carers yet it is currently not known how to treat them. No double-blind clinical trials have been carried out to test drug or non-drug treatment for visual hallucinations specifically and it is currently unclear what trials should be trying to achieve. SHAPED-TF is a workstream within the NIHR-funded SHAPED programme (Study of Hallucinations in Parkinson’s Eye disease and Dementia) tasked with obtaining data from which to design future large-scale treatment trials. Its primary objective is to find out what to expect in a trial setting in terms of rates and characteristics of hallucinations and patient views on treatment options. Secondary objectives are to estimate how effective non-drug approaches to treatment are and, for patients taking medication, how the treatments work.
SHAPED-TF is designed to mirror what happens in current clinical practice with non-drug treatment approaches (eye movements and lighting change) tried before medication. It is not designed to obtain evidence of whether any particular medication works but factors that determine whether a patient chooses to take medication and, for those that do, measure changes in cortical excitability using electroencephalography (EEG) to better understand how the medications work. SHAPED-TF will recruit n=60 patients with persistent visual hallucinations caused either by eye disease, dementia or Parkinson’s disease. Each patient will undergo a assessment at study entry and every 2 weeks after, with a total duration of contact of 6-8 weeks depending on whether the patient responds to non-drug treatments. The main ethical considerations of SHAPED-TF are the inconvenience of repeat assessments and consent in patients with dementia. These issues have been mitigated in the design, policies and procedures of the study.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
17/LO/1971
Date of REC Opinion
4 Dec 2017
REC opinion
Favourable Opinion