The Parkinson's Pain Study


Study ID: 15047
Short Title: The Parkinson's Pain Study
Organisation: UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST
Location: SOUTHAMPTON GENERAL HOSPITAL
Condition: Parkinson's disease
Main Specialty: Neurological disorders
Expected End Date: 02/09/2019
Postcode: SO16 6YD
Contact Name: UHS R&D Office
Contact Email: R&Doffice@uhs.nhs.uk
Active: Yes

Inclusion Criteria

All patients in the Proband Study and the Oxford Monument Disovery study will be considered for entry into the Parkinson's Pain Study. These are the Inclusion criteria for the Proband study.


1) Diagnosis of Parkinson’s disease, based on UK Brain Bank criteria and made within the preceding 3 years (‘recent onset cases’) or diagnosed at under 50 years (‘under 50 years cases’).


2) Age ?18 to < 90years 3)Subject is able and willing to provided informed consent.


These are the Inclusion Criteria for the Oxford Monument Discovery Study:


1) Participant is willing and able to give informed consent for participation in the study. Should be fluent in English.


2) Male or Female, aged 18 years or above.


3) For patients: there must be a clear diagnosis of PD made by a Neurologist with expertise in this disease.


4) No evidence of significant cognitive impairment.


5) For controls: must be age and sex strata matched.

Exclusion Criteria

All patients in the Proband Study and the Oxford Monument Disovery study will be considered for entry into the Parkinson's Pain Study. These are the Exclusion criteria of the Proband Study.


1) Patient has severe comorbid illness that would prevent full study participation.


2) Patient has features indicating another type of degenerative parkinsonism, e.g. progressive supranuclear palsy.


3) Drug induced parkinsonism (Drug unmasked PD is allowed).


4) Symmetrical lower body parkinsonism attributable to significant cortical and/or subcortical cerebrovascular disease (patients with ‘incidental’ small vessel disease on brain imaging are allowed).


5) Negative or normal functional imaging of the presynaptic dopamine system.


6) The presence of UK Brain Bank exclusion criteria will be recorded at baseline, allowing for the presence of 1 or 2 exclusion criteria (e.g. dopamine antagonist Drug used? more than one affected relative) (if justified e.g. by abnormal SPECT).


These are the Exclusion criteria of the Oxford Monument Discovery Study.


1) Inability to provide informed consent or withdrawal of consent at any stage. Medical or psychiatric illness that would interfere with completing initial or follow-up assessments.


2) Severe mental impairment due to dementia or psychosis.


3) Pregnancy.


4) Contraindication to lumbar puncture e.g. bleeding diathesis, epidural abscess, suspicion of raised intracranial pressure.


5) Contraindication to MRI e.g. incompatible metal foreign body or suspicion of such.


6) Contraindication to saccadometry e.g. double vision or serious eye disease.

Study summary:

Over half of patients with Parkinson's disease suffer from chronic pain. Despite this, there has not been much research on pain in Parkinson's disease. The primary aim of this study is to increase our understanding of pain in Parkinson's disease, and identify biomarkers of pain. Biomarkers are small changes in the body that can help with diagnosis, tracking the disease and explaining the disease mechanism. In this case we hope that biomarkers will explain why some patients develop pain and help direct treatment.

Our study is called the Parkinson’s Pain study. This will run alongside two separate studies: the Proband study, and the Oxford Monument Discovery Study. Both the Proband study and the Oxford Discovery Study are already running and have been given favourable ethical approval. These are two of the world’s largest ever in-depth studies of people with Parkinson's. Between them, they are aiming to recruit almost 4000 patients with Parkinson's disease from many centres around the UK between 2012 and 2017. All patients in the these studies will have detailed assessments of their Parkinson's disease symptoms, as well as having blood samples taken to identify biomarkers. The Proband study and the Oxford Discovery study are not investigating pain in Parkinson's disease and therefore will not be able to find biomarkers of pain in Parkinson's disease. However these studies were always meant to encourage people to add other studies onto it. We want to add a brief (20 minute) assessment of pain onto one of the Proband study and the Oxford Monument Discovery Study visits. We will be able to combine the information from our study with the other detailed assessments in these studies to help us understand pain in Parkinson's disease.


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