Status:
COMPLETED
Cervical Electrical Stimulation for ALS
Lead Sponsor:
VA Office of Research and Development
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral sclerosis (ALS). ALS causes degeneration of motor neurons in both the brain and the spinal cord. Evidence from stu...
Detailed Description
Amyotrophic lateral sclerosis (ALS) reduces connections between the cortical motor neurons that initiate movement and the spinal motor neurons that direct muscles to execute movement. This situation s...
Eligibility Criteria
Inclusion
- Inclusion Criteria (ALS):
- Age between 21 and 75 years
- Diagnosis of probable or definite ALS (or non-disabled volunteer)
- Incomplete weakness of left or right wrist or hand muscles:
- score of 2, 3, or 4 (out of 5) on manual muscle testing of:
- wrist flexion
- finger extension
- finger flexion
- or finger abduction
- Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation and/or adductor digiti minimi (ADM) to ulnar nerve stimulation
- US Veteran or non-Veteran
- Inclusion Criteria (Participants without neurological disease):
- Age between 21 and 75 years
- No history of significant neurological disease
- Detectable F-wave responses of the left or right APB to median nerve stimulation and/or ADM to ulnar nerve stimulation
- US Veteran or non-Veteran
- Exclusion Criteria (ALS):
- History of other serious injury or disease of central or peripheral nervous system
- History of seizures
- Ventilator dependence or patent tracheostomy site
- Use of medications that significantly lower seizure threshold
- History of head trauma with evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging
- History of implanted:
- brain/spine/nerve stimulators
- aneurysm clips
- ferromagnetic metallic implants
- or cardiac pacemaker/defibrillator
- Significant coronary artery or cardiac conduction disease
- History of bipolar disorder or suicide attempt or active psychosis
- Heavy alcohol consumption (\> equivalent of 5 oz of liquor) within previous 48 hours
- Open skin lesions over the face, neck, shoulders, or arms
- Pregnancy
- Unsuitable for study participation as determined by study physician
- Exclusion Criteria: (Participants without neurological disease)
- History of other serious injury or disease of central or peripheral nervous system
- History of seizures
- Ventilator dependence or patent tracheostomy site
- Use of medications that significantly lower seizure threshold
- History of head trauma with evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging
- History of implanted:
- brain/spine/nerve stimulators
- aneurysm clips
- ferromagnetic metallic implants
- or cardiac pacemaker/defibrillator
- Significant coronary artery or cardiac conduction disease
- History of bipolar disorder or suicide attempt or active psychosis
- Heavy alcohol consumption (\> equivalent of 5 oz of liquor) within previous 48 hours
- Open skin lesions over the face, neck, shoulders, or arms
- Pregnancy
- Unsuitable for study participation as determined by study physician
Exclusion
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03411863
Start Date
January 4 2018
End Date
June 1 2021
Last Update
October 25 2022
Active Locations (1)
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1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468