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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00892-39 |
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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).
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The step length (expressed in meter) | from day 1 (without L Dopa) to day 2 (with L Dopa) |
| Measure | Description | Time Frame |
|---|---|---|
| The gait speed | from day 1 (without L Dopa) to day 2 (with L Dopa) | |
| The step cadence | From day 1 (without L Dopa) to day 2 (with L Dopa) | |
| The number of freezing |
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Inclusion Criteria:
Healthy subject
Exclusion Criteria:
Healthy subject
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel COUDEYRE | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| from day 1 (without L Dopa) to day 2 (with L Dopa) |
| The UPDRS score | from day 1 (without L Dopa) to day 2 (with L Dopa) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |