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

Not Applicable

Terminated

• Conditions: Painful Avulsion of Brachial Plexus
• Interventions: Procedure: fMRI; Procedure: mTMS

• Registration Number: NCT01104506
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-12-13
• Last Update Posted: 2010-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Painless plexus	fMRI	Patient with a painless avulsion of brachial plexus
Painless plexus	mTMS	Patient with a painless avulsion of brachial plexus
Healthy	fMRI	Healthy volunteers
Healthy	mTMS	Healthy volunteers
Painful plexus	fMRI	Patient with a painful avulsion of brachial plexus
Painful plexus	mTMS	Patient with a painful avulsion of brachial plexus

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of primary outcome depending on cortical center		Calculation of cortical center evoking the maximal PEM
Evaluation of primary outcome depending on the center of cortical area		Calculation of the center of the cortical area suggestive of a precised muscle
Evaluation of primary outcome depending on cortical surface		Calculation of cortical surface suggestive of a precised muscle
Pain intensity		Pain intensity by using an visual analogic scale
Ghost sensations intensity		Ghost sensations intensity by a questionnaire
Amplitude of PEM		calculation of the amplitude of PEM for a precised muscle.

Trial Locations

Locations (1)

Nantes UH; 🇫🇷 Nantes, France