Spinal Cord Associative Plasticity for ALS

Part of paid clinical trials in The Bronx, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT06172621
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Associative Plasticity (SCAP) — PROCEDURE
    Paired non-invasive brain and spinal cord stimulation.
  • Upper extremity task-oriented exercise — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468-3904
Francisco E Castano, MPH
[email protected]
718-584-9000
Noam Y Harel, MD PhD
[email protected]
(718) 584-9000
Noam Y. Harel, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
James J. Peters VA Medical Center, Bronx, NY· The Bronx, NY

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