CALLIOPE Study
Research type
Research Study
Full title
CALLIOPE: Use and evaluation OF PDMONITOR® use in people WITH PARKINSON’S (PwPs).
IRAS ID
292425
Contact name
Kallol Chaudhuri
Contact email
Sponsor organisation
PD Neurotechnology Ltd
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Calliope study is designed to evaluate the clinical utility of a
recording device for Parkinson’s Disease, the PDMonitor®, by
patients and physicians and to record any possible changes in
patients’ QoL.
Main objective
To Determine the satisfaction of patients and physicians from the PDMonitor® recording device, as evaluated by patient and
physician satisfaction questionnaires
The study consists of four
on site visits and two periods of three months PDMonitor® Recording sessions
I. Visit 0 (Screening) with Informed Consent and Eligibility Assessment. Data regarding their clinical status without using
the device will be collected as part of clinical practice
II. Visit 1 (Enrollment) with clinical evaluation, main patient questionnaires, patient training to the PDMonitor® and
allocation of the participant ID number, providing device to the patient for home use.
III. Visit 2 (3 months FU). A 3-month follow-up visit where physicians have access and evaluate the PDMonitor ® reports.
PDQ-39 and clinical impression questionnaires. Physicians are free to perform any medication or treatment changes.
IV. Visit 3 (6month FU/EOS). A 6-month follow-up visit where changes in patient quality of life and motor status as well
as adherence to PDMonitor use are evaluated.
The target number of patients is : 6-10 patients/site to be enrolled
INCLUSION CRITERIA
▪Diagnosed with PD
▪Age 18-90
▪Motor fluctuations
▪≥ 2 Hours OFF time and/or LID
▪Willing and able to sign Inform Consent.
EXCLUSION CRITERIA
▪ Inability to communicate independently, with or without supportive communication tools.
Patients who have caregiver/family could be enrolled in the study.
▪ Unable or unwilling to commit to study procedures.
▪ Coexisting Idiopathic Tremor or tremor of any other cause except PD.
▪ Coexisting diagnosis of vascular parkinsonism.
▪ Coexisting paresis of any limb as a result of vascular disease or any other cause.
▪ Coexisting severe psychiatric disease.
▪ Any other severe comorbidities that could impair patients’ gait more than Parkinson’sDisease. More info is provided in protocol.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0211
Date of REC Opinion
12 Oct 2021
REC opinion
Further Information Favourable Opinion