NCT06172621 · VA Office of Research and Development
Spinal Cord Associative Plasticity for ALS
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
Spinal Cord Associative Plasticity (SCAP)
Paired non-invasive brain and spinal cord stimulation.
PROCEDURE
Upper extremity task-oriented exercise
Participants will perform a range of exercises composed of tasks resembling daily home/community activities such as stacking and sorting small objects, manipulating writing utensils, keys, buttons, etc.
Primary outcome measures
Amplitude of intrinsic hand muscle response to single-pulse transcranial magnetic stimulation (TMS)
Time frame: Through study completion, up to 6 months
The primary neurophysiological outcome will be corticospinal excitability measured at the first dorsal interosseous (FDI) muscle. If no suitable FDI muscle, will substitute with abductor pollicis brevis (APB) muscle.
Hand dexterity on the nine-hole peg test
Time frame: Through study completion, up to 6 months
Time to complete placement of nine pegs into their respective holes using the target hand.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- The Bronx, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations