Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
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ClinicalTrials.gov Identifier: NCT01897818 |
Recruitment Status : Unknown
Verified May 2013 by Centre Hospitalier Universitaire de Nice.
Recruitment status was: Recruiting
First Posted : July 12, 2013
Last Update Posted : July 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Device: communication system P300 Speller | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Study Start Date : | July 2013 |
Estimated Primary Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: ALS patients |
Device: communication system P300 Speller |
- the full achievement of "copy spelling" and "free spelling" tests session 1 [ Time Frame: 14 days after inclusion ]
- the full achievement of "copy spelling" and "free spelling" tests session 2 [ Time Frame: 28 days after inclusion ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age >= 18
- have a diagnosis of ALS suspected, possible, probable with EMG
- be able to follow the study process and to comply with the schedule of visits upon entry into the study
- understand the purpose of the study
- expressing P300 wave in the conditions of the study
Exclusion Criteria:
- have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study
- have a significant history of photosensitive epilepsy
- have a history of allergy to the gel used for the electrodes
- Major protected by law (guardianship, curators)
- have uncorrectable visual disorders
- not being able to maintain a sitting position and focus on a computer screen for more than 30 min.

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): NCT01897818
Contact: Claude DESNUELLE, Pr | desnuelle.c@chu-nice.fr |
France | |
Hôpital de l'Archet I | Recruiting |
Nice, France, 06202 | |
Contact: Claude DESNUELLE, Pr desnuelle.c@chu-nice.fr | |
Principal Investigator: Claude DESNUELLE, Pr |
Responsible Party: | Centre Hospitalier Universitaire de Nice |
ClinicalTrials.gov Identifier: | NCT01897818 |
Other Study ID Numbers: |
12-PP-16 |
First Posted: | July 12, 2013 Key Record Dates |
Last Update Posted: | July 12, 2013 |
Last Verified: | May 2013 |
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 |