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)

This study has been terminated.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01104506
First received: April 8, 2010
Last updated: December 13, 2010
Last verified: April 2010
  Purpose

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 Intervention
Painful Avulsion of Brachial Plexus
Procedure: fMRI
Procedure: mTMS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus. [ Designated as safety issue: No ]
    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:
  • Evaluation of primary outcome depending on cortical center [ Designated as safety issue: No ]
    Calculation of cortical center evoking the maximal PEM

  • Evaluation of primary outcome depending on the center of cortical area [ Designated as safety issue: No ]
    Calculation of the center of the cortical area suggestive of a precised muscle

  • Evaluation of primary outcome depending on cortical surface [ Designated as safety issue: No ]
    Calculation of cortical surface suggestive of a precised muscle

  • Pain intensity [ Designated as safety issue: No ]
    Pain intensity by using an visual analogic scale

  • Ghost sensations intensity [ Designated as safety issue: No ]
    Ghost sensations intensity by a questionnaire

  • Amplitude of PEM [ Designated as safety issue: No ]
    calculation of the amplitude of PEM for a precised muscle.


Enrollment: 13
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01104506

Locations
France
Nantes UH
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Anne OMNES, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01104506     History of Changes
Other Study ID Numbers: BRD 10/2-A, 2010-A00141-38
Study First Received: April 8, 2010
Last Updated: December 13, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 19, 2014