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)

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.

Study Overview

• Status: Terminated
• Conditions: Painful Avulsion of Brachial Plexus
• Intervention / Treatment: Procedure: fMRI; Procedure: mTMS

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Nantes UH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Painless plexus; Patient with a painless avulsion of brachial plexus	Procedure: fMRI; Procedure: mTMS
Active Comparator: Healthy; Healthy volunteers	Procedure: fMRI; Procedure: mTMS
Experimental: Painful plexus; Patient with a painful avulsion of brachial plexus	Procedure: fMRI; Procedure: mTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (Estimate): April 15, 2010

Study Record Updates

• Last Update Posted (Estimate): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Avulsion
• Other Study ID Numbers: BRD 10/2-A; 2010-A00141-38 (Other Identifier: Afssaps)