ADROIT
Research type
Research Study
Full title
Abbott DBS Post-Market Study of Outcomes for Indications over Time
IRAS ID
273354
Contact name
Keyoumars Ashkan
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 1 months, 1 days
Research summary
The purpose of this research study is to collect long-term, real-world data on the safety and effectiveness of all Abbott, CE marked, commercially available deep brain stimulator (DBS) devices. The clinical investigation will enrol eligible patients diagnosed with Parkinson’s disease, essential tremor or other disabling tremor, and dystonia who are scheduled for a new implant or implantable pulse generator device replacement surgery with a market-released Abbott DBS system.\n\nParticipant enrolment is expected to be completed within 5 years. Each participant will be followed for 5 years after the initial programming visit. Study visits and data collection will take place at baseline, implant (standard of care visit), initial programming (standard of care visit), 6 months after initial programming, and then annually for 5 years after initial programming.\n\nThe PI or designee will discuss the study with those patients that meet the eligibility criteria and follow the informed consent procedure detailed in ISO 14155 and detailed in the study CIP. For minor, legal authorised representation will be sought. Patients unable to read or write will provide verbal consent and a witness will sign and date the consent form. Caregivers be consented for data collection where applicable. \n\nStandard-of-care, medical and movement disease history, complications and healthcare utilisation data will be collected. Self-reported QoL-, mood and condition-specific questionnaires will be administered to participants. Caregivers will be asked to complete a movement questionnaire (Caregivers Global Impression) and health burden questionnaire (Zarit Burden Interview) with regards to the participant. \n\nThe study will enrol up to 1,000 participants across 50 international sites where Abbott DBS systems are approved. Since there are no statistically powered endpoints, there is no required sample size for the study. The total duration of the study is expected to be 11 years, including enrolment, data collection from all subjects, and study close out.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0182
Date of REC Opinion
24 Jan 2020
REC opinion
Further Information Favourable Opinion