Paired brain and spinal stimulation with hand exercises for ALS
Tests paired brain and spinal stimulation, with or without hand exercises, in adults with ALS.
Plain-language title generated from the registry record
Registry title: Spinal Cord Associative Plasticity for ALS
Key facts
- Where
- The Bronx, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06172621, who can take part
Where in United States
- James J. Peters VA Medical Center, Bronx, NYThe Bronx, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- VA Office of Research and Development
- Trial code
- NCT06172621
- Record updated
- 20 March 2026
- Original description
Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral sclerosis (ALS).Read full original descriptionShow less
Spinal Cord Associative Plasticity for Amyotrophic Lateral Sclerosis
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.
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 severe head trauma (evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging); 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; History of seizures; Use of medications that significantly lower seizure threshold, such as amphetamines and dalfampridine; 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; History of significant tinnitus; History of bipolar disorder; History of suicide attempt; 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; Ventilator dependence or patent tracheostomy site; Active psychosis; Open skin lesions over the neck, shoulders, or arm stimulation or recording sites; Pregnancy.