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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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01104506
Acronym
CCPB
Enrollment
13
Registered
2010-04-15
Start date
2010-04-30
Completion date
2010-09-30
Last updated
2010-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful Avulsion of Brachial Plexus

Brief summary

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.

Interventions

PROCEDUREfMRI
PROCEDUREmTMS

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Secondary

MeasureTime frameDescription
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
Amplitude of PEMcalculation of the amplitude of PEM for a precised muscle.
Pain intensityPain intensity by using an visual analogic scale
Ghost sensations intensityGhost sensations intensity by a questionnaire
Evaluation of primary outcome depending on cortical surfaceCalculation of cortical surface suggestive of a precised muscle

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026