Parkinson's DiseasePhase 4NCT01782638
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
A Phase 4 study testing deep brain stimulation in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- deep brain stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to 23 Apr 2013
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients :
- Men or women aged between 45 -85 years
- Patients with an idiopathic Parkinson's disease according to UKPDSBB criteria
- Normal neurologic evaluation (except Parkinson's disease)
- Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
- Affiliated to National Health system
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- Having given their informed consent
- Healthy subject
- Men or women aged between 45 -85 years
- Normal neurologic evaluation
- Affiliated to National Health system
- Having given their informed consent
Who cannot join
- Patients :
- Patients suffering of an atypical Parkinson syndrome
- Patients with locomotive disorders which can interfere in gait evaluation
- Patients with dementia (MMS <24)
- Under guardianship
- In excluding period for another study
Show all 12Show fewer
- Person who participate to an other study
- Healthy subject
- Subject with locomotive disorders which can interfere in gait evaluation
- Subject with dementia (MMS <24)
- Under guardianship
- In excluding period for another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.
Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area.
The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
Read the detailed description
A randomized, double-blind, parallel-group study 2 groups of patients: 10 patients with electrodes placed in STN and 10 patients with electrodes placed in Forel fields.
1 group of healthy paired-control (n=20).
Patients will be evaluated without and with treatment on two mornings (J0 and J0+1day).
In each condition of treatment, 3 conditions of stimulation were tested: without stimulation; frequency 25Hz, frequency 130 Hz.
Evaluations consist on :
- motor evaluation (UPDRS)
- gait evaluation (to walk on a gait mat)
- Stand-Walk-Sit Test
- Conditions
- Parkinson's Disease
- Being tested
- deep brain stimulation
- Keywords
- Parkinson's disease, Deep brain stimulation, Gait, Freezing, Electrode placements
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| deep brain stimulation with high frequency | Experimental | The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment). Receives: Behavioral: deep brain stimulation |
| low frequency on gait of patients | Other | The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment). Receives: Behavioral: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The step length (expressed in meter)
Measured: from day 1 (without L Dopa) to day 2 (with L Dopa)
Secondary outcomes (4)
The gait speed
Measured: from day 1 (without L Dopa) to day 2 (with L Dopa)
The step cadence
Measured: From day 1 (without L Dopa) to day 2 (with L Dopa)
The number of freezing
Measured: from day 1 (without L Dopa) to day 2 (with L Dopa)
The UPDRS score
Measured: from day 1 (without L Dopa) to day 2 (with L Dopa)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startSep 2012
- Primary completion23 Apr 2013
- Study completion23 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782638
- Sponsor's protocol ID
- CHU-0140
- Other IDs
- 2011-A00892-39
- Status last verified
- Jan 2013
- First submitted
- 21 Jan 2013
- Last updated
- 15 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.
- ClinicalTrials.gov ID
- NCT01782638
- Acronym / sponsor ID
- CHU-0140
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Deep brain stimulation, Gait, Freezing, Electrode placements
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 23 Apr 2013 (actual)
- Study completion
- 23 Apr 2013 (actual)
- First posted
- 4 Feb 2013 (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.
Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area.
The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
Detailed description
A randomized, double-blind, parallel-group study 2 groups of patients: 10 patients with electrodes placed in STN and 10 patients with electrodes placed in Forel fields.
1 group of healthy paired-control (n=20).
Patients will be evaluated without and with treatment on two mornings (J0 and J0+1day).
In each condition of treatment, 3 conditions of stimulation were tested: without stimulation; frequency 25Hz, frequency 130 Hz.
Evaluations consist on :
- motor evaluation (UPDRS)
- gait evaluation (to walk on a gait mat)
- Stand-Walk-Sit Test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep brain stimulation with high frequency | Experimental | Behavioral: deep brain stimulationThe primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment). |
| low frequency on gait of patients | Other | Behavioral: deep brain stimulationThe primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment). |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients :
- Men or women aged between 45 -85 years
- Patients with an idiopathic Parkinson's disease according to UKPDSBB criteria
- Normal neurologic evaluation (except Parkinson's disease)
- Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
Key exclusion criteria (12 listed)
- Patients :
- Patients suffering of an atypical Parkinson syndrome
- Patients with locomotive disorders which can interfere in gait evaluation
- Patients with dementia (MMS <24)
- Under guardianship
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 |
|---|---|---|
| deep brain stimulation | Behavioural | deep brain stimulation with high frequency, low frequency on gait of patients |
Primary outcome
The step length (expressed in meter)
Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
4 secondary outcomes
The gait speed
Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
The step cadence
Time frame: From day 1 (without L Dopa) to day 2 (with L Dopa)
The number of freezing
Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
The UPDRS score
Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
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 15 Feb 2024.
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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.
Emmanuel COUDEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing deep brain stimulation in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand 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 12 inclusion and 12 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 15 Feb 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The step length (expressed in meter) (time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)). 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 15 Feb 2024.