Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain (CCPB)
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|ClinicalTrials.gov Identifier: NCT01104506|
Recruitment Status : Terminated
First Posted : April 15, 2010
Last Update Posted : December 14, 2010
In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This purpose of this study is to realise a precise mapping of the primary motor cortex post brachial plexus avulsion.
The principal endpoints is to identify and test the reliability of a muscular marker for which the cortical representation is localized immediately next to the superior member area. Several muscles of cephalic, cervical and chest area will be investigate.
The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional MRI.
Concerning mTMS, several methods will be tested: best position on the scalp, realisation of outputs maps with extreme points average method, with mass center method.
Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand, blow up and down abdomen, eyes winking.
Statistical tests will confirm the best muscle candidate and will permit to evaluate the reliability of the method.
|Condition or disease||Intervention/treatment||Phase|
|Painful Avulsion of Brachial Plexus||Procedure: fMRI Procedure: mTMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Active Comparator: Painless plexus
Patient with a painless avulsion of brachial plexus
Active Comparator: Healthy
Experimental: Painful plexus
Patient with a painful avulsion of brachial plexus
- Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus.Spatial coordinates (xyz): calculation of the center of gravity of cortical surface suggestive of a specific muscle, using data acquired during each session.
- Evaluation of primary outcome depending on cortical centerCalculation of cortical center evoking the maximal PEM
- Evaluation of primary outcome depending on the center of cortical areaCalculation of the center of the cortical area suggestive of a precised muscle
- Evaluation of primary outcome depending on cortical surfaceCalculation of cortical surface suggestive of a precised muscle
- Pain intensityPain intensity by using an visual analogic scale
- Ghost sensations intensityGhost sensations intensity by a questionnaire
- Amplitude of PEMcalculation of the amplitude of PEM for a precised muscle.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104506
|Nantes, France, 44000|