NCT01897818

Brief Summary

ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

July 12, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

July 9, 2013

Last Update Submit

July 9, 2013

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (2)

  • the full achievement of "copy spelling" and "free spelling" tests session 1

    14 days after inclusion

  • the full achievement of "copy spelling" and "free spelling" tests session 2

    28 days after inclusion

Study Arms (1)

ALS patients

EXPERIMENTAL
Device: communication system P300 Speller

Interventions

communication system P300 SpellerDEVICE
ALS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de l'Archet I

Nice, 06202, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Claude DESNUELLE, Pr

CONTACT

desnuelle.c@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Last Updated

July 12, 2013

Record last verified: 2013-05

Locations

FR(1)