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Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959373
Recruitment Status : Suspended
First Posted : October 10, 2013
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not always easy to establish. The only technique used in routine to assess the corticospinal dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is largely dependent on LMN state and is based on artificial motor cortex activation.

The main objective of our study project is to evaluate a new method assessing functional changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical coherences, it could be possible to show modifications in both cortico-muscular relationship and in cortical activity coordination which could be related to clinical state in ALS patients. We notably expect a decrease in cortico-muscular coherence in ALS patients. Furthermore, these analyses could provide new insights in motor system plasticity phenomena. We expect a partial covering of voluntary motor command by cortical areas adjacent to primary motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor control may be assumed by ipsilateral corticospinal tract could be tested by coherence analyses.

Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This method has the advantage to be painless and not to use artificial stimulations as it is used in TMS.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: electroencephalograms (EEG) Procedure: electro-myography (EMG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis
Study Start Date : October 2013
Actual Primary Completion Date : July 2014


Arm Intervention/treatment
Experimental: patients Procedure: electroencephalograms (EEG)
Procedure: electro-myography (EMG)
Experimental: healthy volunteers Procedure: electroencephalograms (EEG)
Procedure: electro-myography (EMG)



Primary Outcome Measures :
  1. recording neuronal activities [ Time Frame: 12 months ]
    simultaneous recording of brain activity using electrodes attached to the scalp and muscle activities of muscles of the hands with electrodes bonded to the skin.


Secondary Outcome Measures :
  1. identify plasticity phenomena [ Time Frame: 12 months ]
    identify plasticity phenomena used in the cortex during the disease. The question is whether a reorganization of cortical networks could preserve, temporarily, the ability of patients to perform muscle contractions which case to determine the nature of the changes induced



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient female or male, more than 18 years,
  • Patien with a diagnosis of amyotrophic lateral sclerosis according to the El Escorial criteria of Brooks et al. 1994
  • Patient , the beginning of the SLA date less than 12 months,
  • Patient not having a familial form of ALS,
  • Patient not having cancer, autoimmune disease, liver failure, severe hypertension or untreated, severe conduction disorders or uncontrolled arrhythmia
  • Patient not having a chronic psychiatric disease, dementia.
  • Patient with normal visual function
  • Patients receiving social coverage
  • Patient have read, understood and signed an informed consent after information

Exclusion Criteria:

  • Patient minor
  • Patient with a familial form of ALS,
  • Patient associated with severe progressive disease (cancer, autoimmune disease , liver failure )
  • Patient (s) with chronic mental illness, dementia ,
  • Presence of atypical clinical signs such as cerebellar ataxia , extrapyramidal signs, sensory disorders , autonomic dysfunction .
  • Clinical signs of chronic respiratory failure or slow and / or forced less than 70% of the theoretical value or chronic hypercapnia than 45 mmHg vital capacity .
  • Patient private freedom following a judicial or administrative decision
  • Patient major Trust
  • Pateinte pregnant, parturient , lactating
  • Patient major in legal protection ( guardianship )
  • Pateinte pregnant , parturient , lactating
  • Patient hospital without consent
  • Patient admitted in a health or social establishment for purposes other than research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959373


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01959373    
Other Study ID Numbers: 2013-A00802-43
2013-22 ( Other Identifier: AP HM )
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases