NCT06172621Recruiting

Spinal Cord Associative Plasticity for ALS

Spinal Cord Associative Plasticity for Amyotrophic Lateral Sclerosis

Source: ClinicalTrials.gov · Last updated 20 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 32 (estimated)
First submitted: 6 Dec 2023
Start date: 1 Apr 2024
Primary completion date: 30 Nov 2027
Lead sponsor: VA Office of Research and Development
Diseases: ALS (motor neurone disease)
NCT number: NCT06172621

What you commit to

Study type: Interventional
Planned participants: 32
From 1 Apr 2024 to the primary completion date, 30 Nov 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Lab values

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

Other

Ventilator dependence or patent tracheostomy site
Active psychosis
Open skin lesions over the neck, shoulders, or arm stimulation or recording sites
Pregnancy

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
James J. Peters VA Medical Center, Bronx, NY Coordinator of this site? Confirm its status	The Bronx	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.