Status:
RECRUITING
Spinal Cord Associative Plasticity for ALS
Lead Sponsor:
VA Office of Research and Development
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral sclerosis (ALS). The investigators have shown that synchronized stimulation over the brain and cervical spinal co...
Detailed Description
Amyotrophic lateral sclerosis (ALS) is more prevalent in Veterans than civilians, leading to ALS being considered a Service-Connected condition by the VA. ALS features incomplete degeneration of upper...
Eligibility Criteria
Inclusion
- Diagnosis of ALS by Gold Coast Criteria (Shefner et al. 2020) or "definite" or "probable" ALS by revised El Escorial Criteria (Brooks et al. 2000)
- Incomplete weakness: Score of 1, 2, 3, or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand
- TSCS-evoked potential amplitude of at least 25 V in left or right abductor pollicis brevis (APB) or first dorsal interosseous (FDI) muscles with a resting motor threshold of 55 mA or lower
- TMS-evoked potential amplitude of at least 25 V in left or right abductor pollicis brevis (APB) or first dorsal interosseous (FDI) muscles with a resting motor threshold of 65% MSO or lower
Exclusion
- History of seizures
- Ventilator dependence or patent tracheostomy site
- Use of medications that significantly lower seizure threshold, such as amphetamines and dalfampridine
- History of severe head trauma (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 in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation
- Significant coronary artery or cardiac conduction disease; heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV
- History of significant tinnitus
- History of bipolar disorder
- History of suicide attempt
- Active psychosis
- Ongoing illicit drug or alcohol abuse in the past 6 months
- Heavy alcohol consumption (greater than equivalent of 5 ounces of liquor) within previous 48 hours
- Open skin lesions over the neck, shoulders, or arm stimulation or recording sites
- Pregnancy
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06172621
Start Date
April 1 2024
End Date
February 29 2028
Last Update
April 6 2025
Active Locations (1)
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1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468-3904