Cyclic versus Continuous DBS in Essential Tremor, Version 1.0
Research type
Research Study
Full title
Cyclic versus Continuous Deep Brain Stimulation in Essential Tremor
IRAS ID
270731
Contact name
Kantharuby Tambirajoo
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Essential Tremor (ET) is a medically debilitating condition causing uncontrollable rhythmic motions during voluntary movements. It is one of the most prevalent movement disorders with a significant impact on a person's quality of life. Deep brain stimulation (DBS) is a proven therapy for the management of medically-refractory ET. Current DBS therapy delivers a constant output, resulting in undesirable side effects and frequent battery changes due to an increase in battery consumption.
This double-blinded randomised study aims to assess the feasibility of a cyclical mode of electrical current delivery on tremor control in ET patients. All patients undergoing DBS for ET at King's College Hospital London will be invited to participate in this study. The aim is to recruit ten patients for the study. Implantation of the DBS will be as per routine surgical protocol.
Participants will be randomised into two groups in a cross-over trial design to have either cyclical or continuous stimulation mode for three months in total. Following this, the trial will be unblinded and open-label follow-up for nine months will be carried out, and patients will continue with device use as per standard practice after the study ends. Participants will be reviewed at regular intervals and will be required to complete questionnaires on their tremor control and quality of life.
This proposal will provide proof of concept for the cyclical mode of stimulation for the treatment of ET resulting in improved battery life, reduced number of operations required for battery changes, reduction in simulation side-effects and enhancing the quality of life.REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1850
Date of REC Opinion
12 Dec 2019
REC opinion
Favourable Opinion