Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease
NCT ID: NCT06005584
Last Updated: 2023-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8 participants
INTERVENTIONAL
2023-06-01
2026-02-28
Brief Summary
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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.
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Detailed Description
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Participants will receive 3 different stimulation parameters in randomised order as outlined below:
1. Burst stimulation
2. High frequency stimulation
3. Sham stimulation Each parameter will last for up to 6 weeks. Both the patients and the researchers assessing the patients will be blinded to the settings parameters. At baseline and at the end of each stimulation settings, the participants will undergo a series of assessments (see secondary outcomes). At the end of the cross-over blinded period, the participants will be unblinded and offered to continue with the parameter that offered most symptomatic relief. The participants will then continue in this setting in an open label phase for another 10 weeks before their final assessment at 7 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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High Frequency SCS
Participants will be randomly assigned to this arm for up to 6 weeks
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.
Burst SCS
Participants will be randomly assigned to this arm for up to 6 weeks
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.
Sham SCS
Participants will be randomly assigned to this arm for up to 6 weeks
Spinal Cord Stimulation - Sham SCS
This intervention will last up to 6 weeks.
Interventions
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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.
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.
Spinal Cord Stimulation - Sham SCS
This intervention will last up to 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
45 Years
85 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Yen Tai
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22CX7894
Identifier Type: -
Identifier Source: org_study_id
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