NCT02313402

Brief Summary

Eighteen ALS patients will be trained to control a new communication device (Eye On Line: EOL) that permit over smooth eye movements to generate digits, letters, words or drawing at will. The intervention consists in a training program during six visits over 3 weeks on site allowing a gradual acquisition of the eye-writing. The primary objective of the study is to assess the feasibility of the use of EOL device in ALS patients. The EOL device potentially offers a creative and personal means of linguistic and emotional expression in subject with motor disability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 26, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

December 5, 2014

Last Update Submit

November 25, 2015

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • recognition by an outside observer of the digits 0-9 produced by the patient with the device

    4 weeks

Secondary Outcomes (1)

  • adverse events

    4 weeks

Study Arms (1)

EOL (Eye On Line)

EXPERIMENTAL

training program allowing a gradual acquisition of the eye-writing

Device: EOL (Eye On Line)

Interventions

EOL (Eye On Line)DEVICE

the intervention consists in training program allowing a gradual acquisition of the eye-writing

EOL (Eye On Line)

Eligibility Criteria

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

You may qualify if:

  • to 65 years old
  • patient with SLA diagnosis
  • patient presenting writing troubles
  • patient with understandable speaking communication
  • patient with health insurance

You may not qualify if:

  • patients presenting oculomotricity troubles
  • patients presenting frontotemporal dementia
  • patients presenting a chronic incapacitating disease other than ALS
  • patients presenting epilepsy antecedents
  • patents included in an other clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitie Salpetriere

Paris, 75013, France

Location

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

Study Officials

  • Lucette Lacomblez, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 10, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-07

Locations

FR(1)