Improving hand strength and function in ALS patients using brain and spinal cord stimulation
Spinal Cord Associative Plasticity for Amyotrophic Lateral Sclerosis
This study is testing a new way to help people with ALS improve their hand strength and function by using brain and spinal cord stimulation along with exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06172621 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance hand strength and function in patients with amyotrophic lateral sclerosis (ALS) through a novel approach that combines synchronized brain and spinal cord stimulation with task-oriented exercises. Initially, each participant will undergo a 2-3 month period to optimize the stimulation intervention tailored to their needs. Following this, the effects of two-week programs of paired brain-spinal stimulation will be compared, with some participants also engaging in hand exercises. The goal is to leverage spinal cord associative plasticity to improve motor output and responses to exercises.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with ALS who exhibit incomplete weakness in hand muscles and meet specific stimulation response criteria.
Not a fit: Patients who are ventilator-dependent, have a history of seizures, or are on medications that lower seizure thresholds may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve hand strength and functional abilities for patients with ALS.
How similar studies have performed: While the approach of combining neuromodulation with exercise is relatively novel in ALS, preliminary data suggest potential benefits from similar methods in spinal cord injury contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
The Bronx, New York
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Noam Y. Harel, MD PhD — James J. Peters Veterans Affairs Medical Center
- Study coordinator: Francisco E Castano, MPH
- Email: francisco.castano@va.gov
- Phone: (718) 584-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.