Amyotrophic Lateral SclerosisNCT01959373
Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis
A study testing electroencephalograms (EEG) and electro-myography (EMG) in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- electroencephalograms (EEG) and electro-myography (EMG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Patient with normal visual function
- Patients receiving social coverage
- Patient have read, understood and signed an informed consent after information
Who cannot join
- 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 .
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- electroencephalograms (EEG), electro-myography (EMG)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalograms (EEG)Procedure or surgery
electro-myography (EMG)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Not described Receives: Procedure: electroencephalograms (EEG); Procedure: electro-myography (EMG) |
| healthy volunteers | Experimental | Not described Receives: Procedure: electroencephalograms (EEG); Procedure: electro-myography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959373
- Sponsor's protocol ID
- 2013-A00802-43
- Other IDs
- 2013-22
- Status last verified
- Aug 2015
- First submitted
- 8 Oct 2013
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT01959373
- Acronym / sponsor ID
- 2013-A00802-43
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Procedure: electroencephalograms (EEG), Procedure: electro-myography (EMG) |
| healthy volunteers | Experimental | Procedure: electroencephalograms (EEG), Procedure: electro-myography (EMG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalograms (EEG) | Procedure or surgery | healthy volunteers, patients |
| electro-myography (EMG) | Procedure or surgery | healthy volunteers, patients |
Primary outcome
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.
1 secondary outcome
identify plasticity phenomena
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalograms (EEG) and electro-myography (EMG) in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recording neuronal activities (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.