ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

The purpose of this study is to determine the muscle strength of a muscle in the thigh after
12 weeks of home exercise.

Eligibility Criteria

Inclusion Criteria:

- Diagnosis of possible, probable or definite amyotrophic lateral sclerosis (ALS) based
on the revised El-Escorial criteria

- Presence in ipsilateral leg of either weakness in any muscle group or of active
denervation by needle electromyography (EMG) which is a surrogate marker of early
denervation

- Ipsilateral quadriceps femoris strength: >=4

- Ambulatory with or without assistance

- Revised ALS Functional Rating Scale (ALSFRS-R) Score > 30

- Forced expiratory vital capacity (FVC) >50% of predicted

Exclusion Criteria:

- ALSFRS-R ≤ 30

- Quadriceps femoris strength <4

- Unable to walk or uses wheelchair as primary means of mobility

- More than mild atrophy of quadriceps

- Bleeding disorder or uptake of anticoagulants

- Unwilling to comply with exercise and needle muscle biopsy

- Not a good research candidate according to the medical opinion of investigator

Principal Investigator

Omar Jawdat, MD

Study Contact

Laura Herbelin, LHERBELIN@kumc.edu, (913) 588-5095

Estimated Completion Date

Tuesday, May 1, 2018

ClinicalTrials.gov #

NCT03201991
06/27/2017