Parkinson DiseaseSCORE-PDNCT06005584
Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease
A study testing Spinal Cord Stimulation - High Frequency SCS and Spinal Cord Stimulation - Burst SCS in people with Parkinson Disease and Freezing of Gait, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait
- What is being tested?
- Spinal Cord Stimulation - High Frequency SCS and Spinal Cord Stimulation - Burst SCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London
Matteo Ciocca, m.ciocca20@imperial.ac.uk
About this study
Official title: Spinal Cord Stimulation to Reduce Imbalance and Falls in Parkinson's Disease
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.
Read more
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.
Read the detailed description
The investigators aim to recruit up to 8 people with Parkinson's with significant gait dysfunction which is resistant to medical therapy to this study. All participants will receive implantation of a spinal cord stimulator at T8-10 levels. The procedure will be done percutaneously. The spinal cord stimulation will be commenced 2-4 weeks after surgery to allow time for recovery.
Participants will receive 3 different stimulation parameters in randomised order as outlined below:
- Burst stimulation
- High frequency stimulation
- 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
- Parkinson Disease, Freezing of Gait
- Being tested
- Spinal Cord Stimulation - High Frequency SCS, Spinal Cord Stimulation - Burst SCS, Spinal Cord Stimulation - Sham SCS
- Keywords
- Spinal Cord Stimulation, Parkinson's, Gait Disorders
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation - High Frequency SCSDevice
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 SCSDevice
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 SCSDevice
This intervention will last up to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Frequency SCS | Active comparator | Participants will be randomly assigned to this arm for up to 6 weeks Receives: Device: Spinal Cord Stimulation - High Frequency SCS |
| Burst SCS | Active comparator | Participants will be randomly assigned to this arm for up to 6 weeks Receives: Device: Spinal Cord Stimulation - Burst SCS |
| Sham SCS | Sham comparator | Participants will be randomly assigned to this arm for up to 6 weeks Receives: Device: Spinal Cord Stimulation - Sham SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Motor symptoms will be measured using the MDS-UPDRS part 3 motor subsection. Part III of the scale will be completed at baseline, visit 1 (1 day post-surgery), visit 2 (6 weeks post-surgery), visit 3 (12 weeks post-surgery), visit 4 (18 weeks post-surgery), visit 4 (28 weeks post-surgery).
The scale consists of four parts; Part I "Non-motor experiences of daily living" (13 questions), Part II "Motor Experiences of daily living" (13), Part III "Motor Examination" (33) and Part IV "Motor Complications" (6).
Each question has five responses that are linked to common clinical terms: 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. "Slight" refers to symptoms with sufficiently low frequency/intensity to cause no impact on function; "Mild" refers to symptoms of frequency/intensity sufficient to cause modest impact on function; "Moderate" refers to symptoms sufficiently frequent/intense to impact considerably, but not prevent, function; "Severe" refers to symptoms that prevent function.
Measured: 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
Scores range: 1-5. Higher scores mean a worse outcome.
Measured: 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
The new freezing of gait questionnaire is a measure of freezing severity (total score range: 0-28) wherein higher scores represent worse freezing behaviour.
The outcome measures represent the change in freezing of gait questionnaire score from pre-intervention (baseline visit) to each post-intervention time point. A larger, positive value represents a greater reduction in freezing severity and a better outcome.
Measured: 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)
Change in the duration to walk 10 meters (in seconds), both in ON-medication. A longer duration to perform the task represents a more impaired mobility.
Measured: 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)
Change in the duration to perform the Timed-Up and Go (TUG) test in seconds, with and without a cognitive dual task, in ON-medication. The Timed Up and Go performance is a measure of mobility, and a longer duration to perform the task represents a more impaired mobility.
Measured: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Changes in 360° turning performance (sec)
Change in the duration to turn 360° in place in ON medication, with and without a cognitive dual task. A longer duration to perform the task represents a more impaired mobility.
Measured: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Mean change in objective, unsupervised quantification of participant motor impairment, using motion sensors
Motor impairment will be determined based on recordings using five sensors (both arms and legs, and lower back) for the entire duration of the trial (PD Monitor, PD Neuroelectrics). Sensors will be placed before the SCS surgery and after each change in SCS parameter, up to the end of the open label phase (28 weeks).
Measured: Baseline, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Change in balance: objective measure of sway velocity on a force platform (metre/sec)
Sway will be measured on a force platform before and after each SCS parameter change, up to 28 weeks post-intervention. Sway metric (sway velocity) will be collected at each time point in five different conditions, namely while standing on an hard surface with eyes open (condition 1) and closed (condition 2), on a soft surface with eyes open (condition 3) and closed (condition 4), and while tandem standing with eyes open (condition 5).
Measured: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Changes in Non-motor Symptoms of PD
Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
Measured: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Changes in Quality of Life Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)
Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.
Measured: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Jun 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen Tai, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005584
- Sponsor's protocol ID
- 22CX7894
- Acronym
- SCORE-PD
- Status last verified
- Aug 2023
- First submitted
- 27 Jan 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Group data can be made available upon request, following completion and publication of results
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation to Reduce Imbalance and Falls in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06005584
- Acronym / sponsor ID
- SCORE-PD / 22CX7894
- Conditions
- Parkinson Disease, Freezing of Gait
- Keywords
- Spinal Cord Stimulation, Parkinson's, Gait Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators aim to recruit up to 8 people with Parkinson's with significant gait dysfunction which is resistant to medical therapy to this study. All participants will receive implantation of a spinal cord stimulator at T8-10 levels. The procedure will be done percutaneously. The spinal cord stimulation will be commenced 2-4 weeks after surgery to allow time for recovery.
Participants will receive 3 different stimulation parameters in randomised order as outlined below:
- Burst stimulation
- High frequency stimulation
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Frequency SCS | Active comparator | Device: Spinal Cord Stimulation - High Frequency SCSParticipants will be randomly assigned to this arm for up to 6 weeks |
| Burst SCS | Active comparator | Device: Spinal Cord Stimulation - Burst SCSParticipants will be randomly assigned to this arm for up to 6 weeks |
| Sham SCS | Sham comparator | Device: Spinal Cord Stimulation - Sham SCSParticipants will be randomly assigned to this arm for up to 6 weeks |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Stimulation - High Frequency SCSHigh Frequency-SCS consists of delivering electrical stimulation at frequencies equal to or greater than 1kHz. This intervention will last up to 6 weeks. | Device | High Frequency SCS |
| Spinal Cord Stimulation - Burst SCSBurst SCS consists of closely spaced, high frequency stimuli delivered to the spinal cord. This intervention will last up to 6 weeks. | Device | Burst SCS |
| Spinal Cord Stimulation - Sham SCSThis intervention will last up to 6 weeks. | Device | Sham SCS |
Primary outcome
Number of Participants with Incidence of Treatment-Emergent Adverse Events
Time frame: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with adverse events that are related to treatment
Number of Participants with Incidence of Serious Adverse Events
Time frame: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with serious adverse events
Number of Participants that complete the study
Time frame: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants that complete the study
10 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Changes in 360° turning performance (sec)
Time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Mean change in objective, unsupervised quantification of participant motor impairment, using motion sensors
Time frame: Baseline, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Change in balance: objective measure of sway velocity on a force platform (metre/sec)
Time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Changes in Non-motor Symptoms of PD
Time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Changes in Quality of Life Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No. Group data can be made available upon request, following completion and publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen Tai principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation - High Frequency SCS and Spinal Cord Stimulation - Burst SCS in people with Parkinson Disease and Freezing of Gait, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen Tai (+442033111182, yen.tai@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Incidence of Treatment-Emergent Adverse Events (time frame: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023; AzTrials last refreshed its copy on 2 Nov 2026.