Spinal Cord Associative Plasticity for Amyotrophic Lateral Sclerosis (ALS)
Background
This is a follow-up of the ‘Spinal Cord Associative Plasticity (SCAP)’ study. People with ALS have spinal cord connectivity problems that resemble those of people with SCI. In people with ALS, we will first determine each individual’s best timing for pairs of brain and cervical spinal cord ‘SCAP’ stimulation, then determine each individual’s best SCAP frequency, and then compare the effects of 2 weeks of repetitive SCAP plus functional hand exercises versus 2 weeks of repetitive SCAP without hand exercises. The goal is to measure the safety and duration of effects of the two-week protocol in the hope of achieving lasting benefit up to 6 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 18-80 years old with a diagnosis of ALS
Ability to at least slightly move muscles of left or right hand, and fingers
No history of severe traumatic brain injury (TBI); no cardiac arrhythmia; 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: 26 visits over a period of 4-6 months.
What should you know
Electrical and magnetic stimulation can feel like a ‘shock’ that is temporarily uncomfortable at higher pulse strength
The main risk of magnetic brain stimulation is seizure. BUT:
The exclusion criteria are designed to prevent anyone at risk of seizure from participating.
When performed according to these recommendations, the risk of seizure is less than 1 in 1,000.
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