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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Suspended

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

electroencephalograms (EEG)

electro-myography (EMG)

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

patients

healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

recording neuronal activities

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

identify plasticity phenomena

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

Full Information

NCT ID

NCT01959373

First Posted

October 8, 2013

Last Updated

August 21, 2015

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT01959373

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Suspended

Study Start Date

October 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients

Arm Type

Experimental

Arm Title

healthy volunteers

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

electroencephalograms (EEG)

Intervention Type

Procedure

Intervention Name(s)

electro-myography (EMG)

Primary Outcome Measure Information:

Title

recording neuronal activities

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

identify plasticity phenomena

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LOIC MONDOLONI

Organizational Affiliation

Assistance Publique Hopitaux De Marseille

Official's Role

Study Director

Facility Information:

Facility Name

Assistance Publique Hopitaux de Marseille

City

Marseille

ZIP/Postal Code

13354

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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