Painful Avulsion of Brachial Plexus Clinical Trial
— CCPBOfficial 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
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.
| Status | Terminated |
| Enrollment | 13 |
| Est. completion date | September 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - For all groups: informed consent, social insurance - For group 1 "painful BPA": consulting to the Nantes'UH for pain of BPA, EVA=4, neurological deficiency partial or total - For group 2 "painless BPA": EVA<4, neurological deficiency partial or total, matching with group 1 on the neurological deficiency - For group 3 "Healthy": matching with group 1 on age ±10 years Exclusion Criteria: - No informed consent - Medical history of epilepsy - Pregnant women - Contra-indication to MRI |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Nantes UH | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No | |
| Secondary | Evaluation of primary outcome depending on cortical center | Calculation of cortical center evoking the maximal PEM | No | |
| Secondary | Evaluation of primary outcome depending on the center of cortical area | Calculation of the center of the cortical area suggestive of a precised muscle | No | |
| Secondary | Evaluation of primary outcome depending on cortical surface | Calculation of cortical surface suggestive of a precised muscle | No | |
| Secondary | Pain intensity | Pain intensity by using an visual analogic scale | No | |
| Secondary | Ghost sensations intensity | Ghost sensations intensity by a questionnaire | No | |
| Secondary | Amplitude of PEM | calculation of the amplitude of PEM for a precised muscle. | No |