Spinal Cord Associative Plasticity for Amyotrophic Lateral Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
James J. Peters VA Medical Center, Bronx, NY
RECRUITING
The Bronx
Contact Information
Primary
Francisco E Castano, MPH
francisco.castano@va.gov
(718) 584-9000
Backup
Noam Y Harel, MD PhD
Noam.Harel@va.gov
(718) 584-9000
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 32
Treatments
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.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov