Electromagnetic field treatment for chronic spinal cord injury patients
The Safety and Efficacy of the Use of a Brain-computer Interface-based Electromagnetic Field Treatment in the Management of Chronic SCI Patients - a Pilot Study
This study is testing a new electromagnetic field treatment to see if it can help improve arm movement in adults with chronic spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | BrainQ Technologies Ltd. Industry-sponsored |
| Locations | 3 sites (Miami, Florida and 2 other locations) |
| Trial ID | NCT04050696 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of the BQ electromagnetic field (EMF) treatment for patients with chronic incomplete spinal cord injuries. Participants will undergo a one-month physical therapy run-in period before receiving the BQ treatment, which utilizes a brain-computer interface to deliver non-invasive electromagnetic fields targeting the central nervous system. The study aims to improve upper limb motor function in individuals aged 18 to 75 with specific motor impairment scores. It is a prospective, single-arm, multicenter study where each subject serves as their own control.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 75 with chronic cervical incomplete spinal cord injuries who have stable motor function and can engage in physical therapy.
Not a fit: Patients with complete spinal cord injuries or those unable to participate in a motor rehabilitation regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance upper limb motor function in patients with chronic spinal cord injuries.
How similar studies have performed: While this approach is innovative, similar studies using electromagnetic field treatments have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and non-pregnant females who are between 18 to 75 years of age 2. Diagnosed with traumatic or (incident-related) non-traumatic chronic cervical incomplete SCI (AIS B-D), 12 to 30 months from event. 3. Individuals with a score between 5 - 35 on the GRASSP strength subscore on at least one side 4. Medically stable 5. Cognitive status and ability to communicate must be at a level consistent with that which is required to participate in motor rehabilitation regimen (e.g. can follow directions and cued tasks) 6. Stable pharmacological treatment plan without any planned modifications 7. Able to engage in physical therapy program as stipulated per protocol 8. Passive shoulder flexion of at least 60 degrees and passive shoulder abduction of at least 40 degrees, to ensure ability to perform upper limb motor tasks 9. Negative pregnancy test in women of childbearing potential 10. Subject can independently provide consent (written or verbal in the presence of a family member) to participate in the study and is willing to comply with study procedures Exclusion Criteria: Subjects not eligible for this study include those that have any of the following: 1. Excessive pain in the UE that limits the administration of the evaluation measurements 2. Excessive spasticity: subjects with MAS of wrist ≥ 2, or MAS of elbow ≥ 3 3. Received botulinum toxin in the previous 4 months, or planning of an upcoming injection during the trial period 4. Participating in any other experimental rehabilitation or drug studies 5. Medical conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation 6. Severe cognitive or psychiatric problems that might significantly impact the successful study conduct 7. History of epileptic seizures or epilepsy 8. Implanted electronic medical devices 9. Alcoholism or drug addiction as defined by DSM-IV within last 5 years
Where this trial is running
Miami, Florida and 2 other locations
- The Miami Project to Cure Paralysis — Miami, Florida, United States (Recruiting)
- Kessler Institute of Rehabilitation — West Orange, New Jersey, United States (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
Study contacts
- Principal investigator: Gabi Zeilig, Ph.D. — Sheba Medical Center
- Study coordinator: Assaf Lifshitz
- Email: assaf@brainqtech.com
- Phone: +972-54-4586787
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.