Parkinson DiseaseSTIMSYMNCT02704195
Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
A study testing Unilateral reduction of stimulation and Chronic Subthalamic nucleus stimulation in people with Parkinson Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Unilateral reduction of stimulation and Chronic Subthalamic nucleus stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2016
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent
Who cannot join
- Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis < 130) Other neurologic or medical pathology interfering with gait
Trial locations and contacts
1 site in 1 country.
About this study
Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease
Read the detailed description
Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied.
In a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.
- Conditions
- Parkinson Disease
- Being tested
- Unilateral reduction of stimulation, Chronic Subthalamic nucleus stimulation
- Keywords
- Parkinson disease, Deep brain stimulation, Freezing of Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral reduction of stimulationProcedure or surgery
30% unilateral reduction of Subthalamic nucleus stimulation
Chronic Subthalamic nucleus stimulationProcedure or surgery
This arm is the reference, with the best stimulation parameters
| Study group | Role | What they receive |
|---|---|---|
| Chronic Subthalamic nucleus stimulation | Active comparator | This arm is the reference, with the best stimulation parameters Receives: Procedure: Chronic Subthalamic nucleus stimulation |
| Unilateral reduction of stimulation | Experimental | 30% unilateral reduction of Subthalamic nucleus stimulation Receives: Procedure: Unilateral reduction of stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of Freezing of gait
the improvement will be measure with a composite score of items 12 + 13 on UPDRS II and items 10+11 on UPDRS III,
Measured: 1 month after new stimulation parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Moro, MD, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704195
- Sponsor's protocol ID
- 2013-A01323-42
- Acronym
- STIMSYM
- Status last verified
- Sep 2016
- First submitted
- 4 Mar 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Meoni S, Debu B, Pelissier P, Scelzo E, Castrioto A, Seigneuret E, Chabardes S, Fraix V, Moro E. Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial. Parkinsonism Relat Disord. 2019 Jun;63:94-99. doi: 10.1016/j.parkreldis.2019.02.032. Epub 2019 Feb 25.
PubMed 30826266
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
- ClinicalTrials.gov ID
- NCT02704195
- Acronym / sponsor ID
- STIMSYM / 2013-A01323-42
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Deep brain stimulation, Freezing of Gait
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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.
Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease
Detailed description
Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied.
In a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Subthalamic nucleus stimulation | Active comparator | Procedure: Chronic Subthalamic nucleus stimulationThis arm is the reference, with the best stimulation parameters |
| Unilateral reduction of stimulation | Experimental | Procedure: Unilateral reduction of stimulation30% unilateral reduction of Subthalamic nucleus stimulation |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent
Key exclusion criteria (1 listed)
- Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis < 130) Other neurologic or medical pathology 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 |
|---|---|---|
| Unilateral reduction of stimulation30% unilateral reduction of Subthalamic nucleus stimulation | Procedure or surgery | Unilateral reduction of stimulation |
| Chronic Subthalamic nucleus stimulationThis arm is the reference, with the best stimulation parameters | Procedure or surgery | Chronic Subthalamic nucleus stimulation |
Primary outcome
improvement of Freezing of gait
Time frame: 1 month after new stimulation parameters
the improvement will be measure with a composite score of items 12 + 13 on UPDRS II and items 10+11 on UPDRS III,
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 30826266Meoni S, Debu B, Pelissier P, Scelzo E, Castrioto A, Seigneuret E, Chabardes S, Fraix V, Moro E. Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial. Parkinsonism Relat Disord. 2019 Jun;63:94-99. doi: 10.1016/j.parkreldis.2019.02.032. Epub 2019 Feb 25.
- 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, MD study director
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral reduction of stimulation and Chronic Subthalamic nucleus stimulation in people with Parkinson Disease, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Sep 2016. 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. 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 was stopped early. Results are not available in the source record.
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?
improvement of Freezing of gait (time frame: 1 month after new stimulation parameters). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704195, which also lists 1 linked publication.
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 21 Sep 2016.