Recruiting

Spinal Cord Plasticity

Sponsor:

VA Office of Research and Development

Code:

NCT06172621

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Associative Plasticity (SCAP)

Upper extremity task-oriented exercise

Study Details

Brief summary:

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

Amyotrophic Lateral Sclerosis

Study ID

NCT06172621

Start date

Apr 1, 2024

Status verified date

Mar, 2026

Completion date

Feb 29, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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
  • Pregnancy

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: SCAP alone

After a run-in phase of 2-4 months to determine individualized stimulation parameters, participants will be randomized into a comparator group of two weeks (6 sessions) of SCAP intervention alone.

experimental: SCAP plus task-oriented exercise

After a run-in phase of 2-4 months to determine individualized stimulation parameters, participants will be randomized into a comparator group of two weeks (6 sessions) of SCAP intervention plus upper extremity task-oriented exercise.

Interventions

Spinal Cord Associative Plasticity (SCAP)

Paired non-invasive brain and spinal cord stimulation.

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 measure

  • Amplitude of intrinsic hand muscle response to single-pulse transcranial magnetic stimulation (TMS) [ Time Frame: Through study completion, up to 6 months ]
  • Hand dexterity on the nine-hole peg test [ Time Frame: Through study completion, up to 6 months ]

Central Contacts and Locations

Central contacts

Francisco E Castano, MPH

(718) 584-9000francisco.castano@va.gov

Noam Y Harel, MD PhD

(718) 584-9000Noam.Harel@va.gov

Locations

James J. Peters VA Medical Center, Bronx, NY

Recruiting

The Bronx, New York, United States, 10468-3904

Contacts

Francisco E Castano, MPH

718-584-9000francisco.castano@va.gov

Noam Y Harel, MD PhD

(718) 584-9000Noam.Harel@va.gov

Principal Investigator:

Noam Y. Harel, MD PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • neuromodulation
  • spinal cord stimulation
  • task-oriented exercise
  • transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-20.