SHS_543110 ELLM CMIC 16089
Hands-Free Wheelchair Pilot Study
This is a pilot study designed to assess the feasibility and initial safety of use of an eye-gaze/hands-free controlled power wheelchair in subjects with amyotrophic lateral sclerosis (ALS) who are wheelchair dependent.
1. Patients 18 years or older
2. Diagnosis of ALS
3. Patient must no longer be ambulatory and wheelchair dependent
1. Clinical evidence of frontotemporal dementia or cognitive impairment
2. On any medical therapy that determined to impair or compromise cognitive function
3. No medical condition or ocular disease that would compromise ocular motility or interfere with eye-gaze tracking system
4. Prior experience using eye-gaze technology
5. Significant axial weakness or head drop that in the opinion of the Investigator would compromise the safety of the patient.
6. Presence of any other condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
7. Upright FVC <50%, MIP > -50, CPF < 200
8. Ventilator dependent
Amyotrophic lateral sclerosis
Michael Elliott, M.D.