Non-Invasive Cervical Stimulation for ALS
Background
Individuals with amyotrophic lateral sclerosis (ALS) have reduced connections in the nerve circuits between the brain and the hands. We are testing different combinations of magnetic and electrical brain and spinal cord stimulation to better understand how nerve circuits interact with each other in ALS, and also to see if we can temporarily improve hand function by activating spared nerve connections.
Note: This is a research study testing for temporary changes in nerve transmission and hand function. There is no expectation of long-term benefit from this study. Any temporary changes seen in this study will be implemented in future studies attempting to prolong that effect.
Eligibility Criteria (summary)
- Age 18-75 with diagnosis of probable or definite Amyotrophic Lateral Sclerosis
- Must have some ability to use fingers in at least one hand
- No history of seizures, cardiac arrhythmia, or implanted electrical devices (pacemaker, spine stimulator, baclofen pump, etc)
- Other eligibility criteria will be screened in person to make sure it is safe for you to participate.
Procedures
If you are an ALS participant, the first visit will be a screening visit to determine your eligibility.
What should you know
- Electrical and magnetic stimulation can feel like a ‘shock’ that is temporarily uncomfortable.
- The main risk of magnetic brain stimulation is seizure. BUT:
- Seizures are riskier when pulses are given faster than once per second – in this study, pulses are never given more than once every 5 or 10 seconds;
- 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
HAR-17-33
Contact
Astrea Villarroel-Sanchez