Improving hand strength and function in ALS patients using brain and spinal cord stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.