SCORE-PD Version 1.0
Research type
Research Study
Full title
Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease
IRAS ID
316212
Contact name
Yen Tai
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Parkinson's disease (PD) is the second commonest neurodegenerative disorder, affecting over 145,000 people in the UK. Initially, PD patients experience slowness of movements, limb stiffness, and tremor. With progressive loss of neurons over time, many patients start to experience balance and walking problems, and falls, which are resistant to currently available treatments. Falls can lead to fractures and nursing home admission, and can significantly shorten patients' life expectancy.
In this pilot study, we will investigate the effects of spinal cord stimulation (SCS) on gait and balance in PD. Some open-labelled studies have shown possible beneficial effects of SCS in PD, although it is uncertain which type of PD patients will benefit most and which stimulation parameters work best. We will assess the effects of SCS on posture and gait using a series of clinical, laboratory, imaging, and wearable measurements.
The participant will be recruited and followed up in Dr Tai’s Movement Disorder Clinic at Charing Cross Hospital. The participants will receive a percutaneous implantation of a spinal cord stimulator to minimise the possible adverse effects related to the surgery. Procedure will be performed by an expert neurosurgeon at Charing Cross Hospital.
The SCS will start one month after surgery. We will use a double- blind, cross-over design, during which patients will receive three different stimulation parameters in a randomised order. Dr Tai will randomise the patient, while the rest of the team and the patient will be blinded to the stimulation parameters. For the sham stimulation, the spinal stimulator will be initially turned on at a low intensity and then it will be turned off. Both the active conditions and the sham stimulation are indistinguishable by patients and researchers.
The study is funded by the MRC and The Jon Moulton Charity Trust.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0371
Date of REC Opinion
3 Jan 2023
REC opinion
Further Information Favourable Opinion