Spinal Cord Associative Plasticity for Amyotrophic Lateral Sclerosis (ALS)
Background
· People with amyotrophic lateral sclerosis (ALS) have reduced nerve connections between the brain and the hands that resemble those of people with SCI. Activating spared nerve connections could be a way to improve recovery.
· We are testing different combinations of magnetic and electrical brain and spinal cord stimulation to see if we can improve hand function by activating spared nerve connections in people with ALS.
· We will first determine each individual’s best timing for pairs of brain and cervical spinal cord stimulation, then determine each individual’s best frequency, and then compare the effects of 1 week of repetitive stim plus functional hand exercises versus 1 week of repetitive stim without hand exercises.
· The goal is to measure the safety and duration of effects in the hope of achieving lasting benefit up to 2 weeks.
· Note: This is a research study testing for temporary changes in nerve transmission and volitional motor function. This is not a cure for ALS. There is no guarantee of long-term benefit from this study. Any benefits seen in this study will be implemented in future studies attempting to augment that effect.
Eligibility Criteria (summary)
· Age 18-85 years old with a diagnosis of ALS.
· Ability to at least slightly move muscles of left or right hand
· No history of severe traumatic brain injury (TBI); not ventilator-dependent; no implanted stimulators or cardiac pacemaker/defibrillator, no epilepsy.
· Other eligibility criteria will be screened in person to make sure it is safe for you to participate
Procedures
· This study involves a significant time commitment: up to 18 visits, 3-4 hours each, over a period of up to 4 months.
· Scheduling is flexible. You do not need to complete all visits.
What you should know
· Electrical and magnetic stimulation can feel like a ‘shock’ or ‘bite’ that is temporarily uncomfortable, especially at higher pulse strength.
o If you ever had an “EMG” or “nerve conduction study” previously, you will already be familiar with this sensation. However, there are no needles used in this study.
· We have never observed a serious adverse event from study procedures during more than 10 years of stimulation studies.
· If you are uncomfortable at any time for any reason, we can stop the procedures. There is no obligation!!
Investigator
Noam Y. Harel, MD, PhD
Study ID
ALS SCAP + HAND
Contact
Sig Sigafose or Francisco Castano
Clinicaltrials.gov Identifier
NCT06172621