Parkinson DiseaseSCM-PARKNCT04682678
Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease
A study testing Implantation of electrodes for Spinal cord stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Implantation of electrodes for Spinal cord stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2021to 11 Jul 2023
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of idiopathic PD
- Aged 50-85 years
- Having a FOG (score> 14 at New-FOG-Questionnaire; score> = 1 at item 2.13 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale) despite the optimization of medical treatment
- Drug treatment stable for at least 2 months
- Able to give written consent.
Who cannot join
- Pain syndrome (score> = 2 at item 1.9 of the MDS-UPDRS II)
- Psychosis
- Severe depression
- Severe cognitive impairment (Mini Mental Score Examination <19)
- Patient receiving STN DBS treatment
- Presence of other neurological or medical pathologies interfering with walking
Show all 10Show fewer
- Subject in period of exclusion from another study
- Subject under administrative or judicial supervision
- Subject who cannot be contacted in an emergency.
- Person with any administrative or judicial measure of deprivation of rights and liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease: a Pilot Study
Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia.
Evaluation of gait and motor symptoms will be performed with and without stimulation, after a 3-month period for each of the stimulation conditions.This is a pilot, single centre, prospective, randomized, double blinded, cross-over study.
Read the detailed description
Patients will be selected in the Movement Disorders Unit, Department of Neurology, University Hospital Grenoble. A preoperative assessment with gait assessment, clinical evaluation and Non-Motor Symptoms assessment will be realized. The implantation of electrodes for SCS at the epidural thoracic level connected to a neurostimulator at the abdominal level will be performed under general anaesthesia. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.After the first post-operative month the patient will be randomized to the STIM ON condition (stimulation on, with the most effective parameters) or STIM OFF (without stimulation). The randomization will be performed in a double blinded fashion, by a neurologist working in open and not participating in the evaluations. After 3 months, the patient will be evaluated in a double blind condition, and the stimulation condition will be crossed for another period of 3 months. At the end of this second 3-month period, the patient will be again double-blind assessed. After this evaluation, the patient will enter the open phase of the study for a period of 6 months. For this last phase of the study, under STIM ON condition, an optimization of the stimulation settings will be realized, if necessary. At the end of this 6-month period of stimulation, the patient will be evaluated one last time. At all visits, clinical and gait evaluations will be carried out under chronic dopaminergic treatment. No change in antiparkinsonian treatment will be allowed during the entire study. Gait and clinical assessment will be performed at baseline and at the end of each double blinded phase and at 1-year follow-up. For the double-blind study the patient, the neurologist who performs the clinical evaluation and the expert who performs the gait test and analysis will be blind to the stimulation condition.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Implantation of electrodes for Spinal cord stimulation
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of electrodes for Spinal cord stimulationProcedure or surgery
The implantation of electrodes for SCS at the epidural thoracic level connected to a neurostimulator at the abdominal level will be performed under general anaesthesia (hospitalization for 3 days in the Neurosurgery Department, CHUGA) in a maximum delay of 1 month following the preoperative assessment. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.
| Study group | Role | What they receive |
|---|---|---|
| OFF STIM | Sham comparator | without stimulation Receives: Procedure: Implantation of electrodes for Spinal cord stimulation |
| ON STIM | Active comparator | stimulation with the most effective parameters Receives: Procedure: Implantation of electrodes for Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency and duration of Freezing Of Gait (FOG) episodes, objective
gait testing
Measured: Month 6
Secondary outcomes (7)
frequency and duration of Freezing Of Gait (FOG) episodes, subjective 1
New FOG-questionnaire (NFOG-Q)
Measured: Month 12
frequency and duration of Freezing Of Gait (FOG) episodes, subjective 2
patient diary
Measured: Month 12
impact of spinal cord stimulation on FOG, long term outcome
New Freezing Of Gait-questionnaire (NFOG-Q)
Measured: Month 12
impact of spinal cord stimulation on quality of life, long term outcome
Parkinsons disease questionnaire (PDQ39)
Measured: Month 12
impact of SCS on gait during a dual cognitive-motor task test
New FOG-questionnaire (NFOG-Q)
Measured: Month 12
impact of SCS on other non-motor symptoms
SCales for Outcomes in PArkinson's disease - Autonomic Dysfunction (SCOPA-AUT)
Measured: Month 12
impact of SCS on gait during timed up and go test
timed up and go test
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start10 Mar 2021
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
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 University Hospital, GrenobleThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena MORO, Principal investigator, CHUGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682678
- Sponsor's protocol ID
- 38RC20.165
- Other IDs
- 2020-A02361-38
- Acronym
- SCM-PARK
- Status last verified
- Oct 2023
- First submitted
- 8 Dec 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT04682678
- Acronym / sponsor ID
- SCM-PARK / 38RC20.165
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 24 Dec 2020 (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.
Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia.
Evaluation of gait and motor symptoms will be performed with and without stimulation, after a 3-month period for each of the stimulation conditions.This is a pilot, single centre, prospective, randomized, double blinded, cross-over study.
Detailed description
Patients will be selected in the Movement Disorders Unit, Department of Neurology, University Hospital Grenoble. A preoperative assessment with gait assessment, clinical evaluation and Non-Motor Symptoms assessment will be realized. The implantation of electrodes for SCS at the epidural thoracic level connected to a neurostimulator at the abdominal level will be performed under general anaesthesia. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.After the first post-operative month the patient will be randomized to the STIM ON condition (stimulation on, with the most effective parameters) or STIM OFF (without stimulation). The randomization will be performed in a double blinded fashion, by a neurologist working in open and not participating in the evaluations. After 3 months, the patient will be evaluated in a double blind condition, and the stimulation condition will be crossed for another period of 3 months. At the end of this second 3-month period, the patient will be again double-blind assessed. After this evaluation, the patient will enter the open phase of the study for a period of 6 months. For this last phase of the study, under STIM ON condition, an optimization of the stimulation settings will be realized, if necessary. At the end of this 6-month period of stimulation, the patient will be evaluated one last time. At all visits, clinical and gait evaluations will be carried out under chronic dopaminergic treatment. No change in antiparkinsonian treatment will be allowed during the entire study. Gait and clinical assessment will be performed at baseline and at the end of each double blinded phase and at 1-year follow-up. For the double-blind study the patient, the neurologist who performs the clinical evaluation and the expert who performs the gait test and analysis will be blind to the stimulation condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFF STIM | Sham comparator | Procedure: Implantation of electrodes for Spinal cord stimulationwithout stimulation |
| ON STIM | Active comparator | Procedure: Implantation of electrodes for Spinal cord stimulationstimulation with the most effective parameters |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diagnosis of idiopathic PD
- Aged 50-85 years
- Having a FOG (score> 14 at New-FOG-Questionnaire; score> = 1 at item 2.13 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale) despite the optimization of medical treatment
- Drug treatment stable for at least 2 months
- Able to give written consent.
Key exclusion criteria (10 listed)
- Pain syndrome (score> = 2 at item 1.9 of the MDS-UPDRS II)
- Psychosis
- Severe depression
- Severe cognitive impairment (Mini Mental Score Examination <19)
- Patient receiving STN DBS treatment
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 |
|---|---|---|
| Implantation of electrodes for Spinal cord stimulationThe implantation of electrodes for SCS at the epidural thoracic level connected to a neurostimulator at the abdominal level will be performed under general anaesthesia (hospitalization for 3 days in the Neurosurgery Department, CHUGA) in a maximum delay of 1 month following the preoperative assessment. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist. | Procedure or surgery | OFF STIM, ON STIM |
Primary outcome
frequency and duration of Freezing Of Gait (FOG) episodes, objective
Time frame: Month 6
gait testing
7 secondary outcomes
frequency and duration of Freezing Of Gait (FOG) episodes, subjective 1
Time frame: Month 12
frequency and duration of Freezing Of Gait (FOG) episodes, subjective 2
Time frame: Month 12
impact of spinal cord stimulation on FOG, long term outcome
Time frame: Month 12
impact of spinal cord stimulation on quality of life, long term outcome
Time frame: Month 12
impact of SCS on gait during a dual cognitive-motor task test
Time frame: Month 12
impact of SCS on other non-motor symptoms
Time frame: Month 12
impact of SCS on gait during timed up and go test
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Elena MORO principal investigator
CHUGA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of electrodes for Spinal cord stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by University Hospital, Grenoble at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 6 Oct 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency and duration of Freezing Of Gait (FOG) episodes, objective (time frame: Month 6). 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 6 Oct 2023.