SONATA study V1.0
Research type
Research Study
Full title
Study of Transition from Open-Loop to Closed-Loop Spinal Cord Stimulation (SONATA)
IRAS ID
363561
Contact name
Anu Kansal
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Spinal cord stimulation (SCS) is a treatment for people with long-term (chronic) pain that has not improved with other treatments. It involves placing small wires (called leads) near the spinal cord. These are connected to a small battery (called an implanted pulse generator, or IPG) that is placed under the skin, usually in the abdomen or buttock. The device sends gentle electrical signals to help reduce pain.
In traditional systems (called “open-loop”), the stimulation is set at a fixed level and is adjusted by the patient using a handheld controller. However, when people change position (for example, lying down or standing up), the stimulation can sometimes feel too strong or not strong enough.
Newer systems use “closed-loop” technology, which automatically adjusts the stimulation in response to changes in the body, so that patients do not need to adjust it themselves.
When patients’ current batteries reach the end of their life (usually after about 9 years), they will be replaced with a new device that can provide both types of stimulation. After a short period using the traditional (open-loop) setting, the device will be switched to the newer closed-loop setting.
This study aims to find out what people who have used SCS for a long time think about their treatment, and how they feel about the newer closed-loop system compared to the traditional one.
Participants will be asked to complete questionnaires before the switch to the new setting and again after 4 months. Some participants will also be invited to take part in an interview to talk about their experiences of living with SCS.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
26/WM/0125
Date of REC Opinion
22 Jun 2026
REC opinion
Favourable Opinion