Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electr… (NCT01782638) | Clinical Trial Compass
CompletedPhase 4
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
France11 participantsStarted 2012-09
Plain-language 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. 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).
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The step length (expressed in meter)
Timeframe: from day 1 (without L Dopa) to day 2 (with L Dopa)