RECRUITING

Spinal Cord Associative Plasticity for ALS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Spinal Cord Associative Plasticity for Amyotrophic Lateral Sclerosis

Quick Facts

Study Start:2024-04-01
Study Completion:2028-02-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06172621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * 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
  3. * 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
  4. * 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
  1. * History of seizures
  2. * Ventilator dependence or patent tracheostomy site
  3. * Use of medications that significantly lower seizure threshold, such as amphetamines and dalfampridine
  4. * History of severe head trauma (evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging)
  5. * 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
  6. * 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
  7. * History of significant tinnitus
  8. * History of bipolar disorder
  9. * History of suicide attempt
  10. * Active psychosis
  11. * Ongoing illicit drug or alcohol abuse in the past 6 months
  12. * Heavy alcohol consumption (greater than equivalent of 5 ounces of liquor) within previous 48 hours
  13. * Open skin lesions over the neck, shoulders, or arm stimulation or recording sites
  14. * Pregnancy

Contacts and Locations

Study Contact

Francisco E Castano, MPH
CONTACT
(718) 584-9000
francisco.castano@va.gov
Noam Y Harel, MD PhD
CONTACT
(718) 584-9000
Noam.Harel@va.gov

Principal Investigator

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

Study Locations (Sites)

James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, 10468-3904
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2028-02-29

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2028-02-29

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis