PROGRESS
Research type
Research Study
Full title
Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
IRAS ID
224314
Contact name
Jibril Osman
Contact email
Sponsor organisation
Abbott (formerly St Jude Medical)
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 28 days
Research summary
This study is for implantable medical device treatment of patients with Parkinson's disease, dystonia and tremor. It will study the effects of Deep Brain Stimulation (DBS).
The sponsor is interested in collecting data to evaluate DBS treatment. DBS is intended to modulate dysfunctional circuits in the brain so that the brain can function more effectively. This is accomplished by sending continuous electrical signals to specific target areas of the brain. The purpose of this study is to support the chronic clinical performance of the Infinity DBS IPG (Implantable Pulse Generator), DBS leads, extensions and related system components. With this data, the sponsor will be able to evaluate the performance of the Infinity Deep Brain Stimulation device for the treatment of Parkinson's disease, tremor and dystonia. The scientific use of the data, which is gathered from this study, may help researchers discover better ways of programming devices to treat movement disorder patients and improving quality of life.
Some of the actions/data collection carried out in this study are part of the normal care and would be done even if the patient were not participating in the study.
The total duration of this study is expected to be approximately 30 months, dependant upon the rate of patient enrolment.
Enrolment will stop when up to 350 participants have received devices.
The patient visits will be enrolment, implant, initial programming, 3, 6 and 12 month follow-ups.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0806
Date of REC Opinion
24 Apr 2018
REC opinion
Further Information Favourable Opinion