Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease

NCT06005584 | Recruiting FDA Device

• 1 other identifier: 22CX7894
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spinal Cord Stimulation; Parkinson's; Gait Disorders

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Incidence of Treatment-Emergent Adverse Events

  Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with adverse events that are related to treatment

  Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

• Number of Participants with Incidence of Serious Adverse Events

  Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with serious adverse events

  Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

• Number of Participants that complete the study

  Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants that complete the study

  Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

Secondary Outcomes (10)

• 1. Mean change from baseline to week 28 in participant scores on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 motor subsection in the "OFF" and "ON" medication state

  Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

• Change in Hoehn and Yahr Scoring Scale

  Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

• Change in New Freezing of Gait Questionnaire

  Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

• Changes in 10 meter walk test (10MW) performance (sec)

  Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

• Changes in Timed Up and Go (TUG) test Performance (sec)

  Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery

Study Arms (3)

High Frequency SCS

ACTIVE COMPARATOR

Participants will be randomly assigned to this arm for up to 6 weeks

Device: Spinal Cord Stimulation - High Frequency SCS

Burst SCS

ACTIVE COMPARATOR

Participants will be randomly assigned to this arm for up to 6 weeks

Device: Spinal Cord Stimulation - Burst SCS

Sham SCS

SHAM COMPARATOR

Participants will be randomly assigned to this arm for up to 6 weeks

Device: Spinal Cord Stimulation - Sham SCS

Interventions

Spinal Cord Stimulation - High Frequency SCS DEVICE

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

High Frequency SCS

Spinal Cord Stimulation - Burst SCS DEVICE

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

Burst SCS

Spinal Cord Stimulation - Sham SCS DEVICE

This intervention will last up to 6 weeks.

Sham SCS

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 45 ≤ X ≤ 85
• PD diagnosis based on UK Parkinson's disease society brain bank criteria
• Significant gait dysfunction, particularly freezing of gait, which is resistant to optimal medical therapy
• Hoen and Yahr stage: 2-4 (in ON state)
• Stable dopaminergic treatment for at least two weeks before enrolment.
• Can provide informed consent

You may not qualify if:

• Atypical or secondary parkinsonism e.g. vascular, drug-induced
• Major focal brain disorders (including malignancy or stroke)
• Recent (within 3 months)/current use of acetylcholinesterase inhibitors or antidopaminergic drugs
• Concomitant treatment with deep brain stimulation
• Neurological, vestibular, visual or orthopaedic diagnosis significantly interfering with gait
• Pregnant women or planning to become pregnant
• Significant chronic back pain
• Spinal anatomical abnormalities precluding SCS surgery
• Major cognitive or psychiatric illness
• Concomitant or recent (less than 4 months) enrolment in an interventional research trial.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yen Tai

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen Tai

CONTACT

+442033111182; yen.tai@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: August 22, 2023
• Study Start: June 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: February 28, 2026
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)