Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease

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, the investigators 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. The investigators will assess the effects of SCS on posture and gait using a series of clinical, laboratory, imaging, and wearable measurements.

The participants will receive a percutaneous implantation of a spinal cord stimulator to minimise the possible adverse effects related to the surgery.

The SCS will start one month after surgery. The investigators will use a double-blind cross-over design. The participants will receive three different stimulation parameters, including sham stimulation, in a randomised order. The participants and the assessors will be blinded to the stimulation parameters.

Conditions

• Parkinson Disease
• Freezing of Gait

Interventions

DEVICE

Spinal Cord Stimulation - High Frequency SCS

High Frequency-SCS consists of delivering electrical stimulation at frequencies equal to or greater than 1kHz. This intervention will last up to 6 weeks.

DEVICE

Spinal Cord Stimulation - Burst SCS

Burst SCS consists of closely spaced, high frequency stimuli delivered to the spinal cord. This intervention will last up to 6 weeks.

DEVICE

Spinal Cord Stimulation - Sham SCS

This intervention will last up to 6 weeks.

Sponsors & Collaborators

• Imperial College London

  lead OTHER

Principal Investigators

• Yen Tai · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2024-10-31

Completion

2026-02-28

FDA Device

Yes

Countries

• United Kingdom

Study Locations