Spinal Cord Associative Plasticity for ALS

This study is looking at a new way to help people with Amyotrophic Lateral Sclerosis (ALS) improve hand strength and function. It uses a treatment called Spinal Cord Associative Plasticity (SCAP), which involves gentle electrical stimulation over the brain and spinal cord. Researchers have already seen that this can temporarily strengthen nerve connections between the brain and hand muscles in people with ALS. This study will personalize the SCAP treatment and then compare it with or without hand exercises. You might be able to join if you are 18 to 80 years old, have a diagnosis of ALS, and have some weakness in your hand muscles. The study will measure improvements in hand muscle response and hand dexterity (skillful use of your hands) for up to 6 months.

Study design
This study plans to enroll 32 participants. It will compare two-week programs of paired brain-spinal stimulation with or without hand exercises after an initial 2-3 month period of optimizing the intervention for each individual.
What's involved
Participants will undergo an initial 2-3 month period to personalize the intervention, followed by two-week programs of paired brain-spinal stimulation, with or without hand exercises. Hand dexterity and muscle response will be measured for up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, for up to 6 months, to measure primary outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06172621

Spinal Cord Associative Plasticity for ALS

Recruiting
NAAges 18–80Interventional
VA Office of Research and Development
~32 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Spinal Cord Associative Plasticity (SCAP)Upper extremity task-oriented exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amplitude of intrinsic hand muscle response to single-pulse transcranial magnetic stimulation (TMS)
Measured over Through study completion, up to 6 months
+1 more outcome measured
Amyotrophic Lateral Sclerosis

NCT06172621

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Noam Y. Harel, MD PhD · PRINCIPAL_INVESTIGATOR · James J. Peters Veterans Affairs Medical Center

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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
  • Amplitude of intrinsic hand muscle response to single-pulse transcranial magnetic stimulation (TMS)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 testThrough study completion, up to 6 months

    Time to complete placement of nine pegs into their respective holes using the target hand.