Actively Recruiting
Spinal Cord Associative Plasticity for ALS
Led by VA Office of Research and Development · Updated on 2026-03-20
32
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 cord can temporarily strengthen weakened nerve circuits between the brain and hand muscles in people with ALS. The current proposal will take the next step of individualizing this intervention, then applying it repetitively in an attempt to achieve direct clinical benefit on hand strength and function. Following an initial 2-3 month period of optimizing the intervention for each individual, the investigators will compare the effects of two-week programs of paired brain-spinal stimulation with or without hand exercises.
CONDITIONS
Official Title
Spinal Cord Associative Plasticity for ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ALS by Gold Coast Criteria or "definite" or "probable" ALS by revised El Escorial Criteria
- Incomplete weakness in finger extension, flexion, or abduction with a muscle strength score of 1 to 4 in either hand
- TSCS-evoked potential amplitude of at least 25 V in left or right hand muscles with resting motor threshold of 55 mA or lower
- TMS-evoked potential amplitude of at least 25 V in left or right hand muscles with resting motor threshold of 65% MSO or lower
You will not qualify if you...
- 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 with brain contusion, hemorrhage, or depressed skull fracture
- History of implanted brain, spine, or nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except inside mouth), cochlear implants, cardiac pacemaker/defibrillator, intracardiac lines, or currently increased intracranial pressure
- Significant coronary artery or cardiac conduction disease; heart failure with ejection fraction less than 30% or NYHA 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 5 ounces of liquor) within previous 48 hours
- Open skin lesions over the neck, shoulders, or arm stimulation or recording sites
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468-3904
Actively Recruiting
Research Team
F
Francisco E Castano, MPH
CONTACT
N
Noam Y Harel, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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