The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients

Launched by BRAINQ TECHNOLOGIES LTD. · Aug 7, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a treatment called BQ Electromagnetic Field (EMF) therapy for patients with chronic incomplete spinal cord injuries (SCI). The goal is to see if this treatment is safe and effective for individuals who have stable strength scores after going through a month of physical therapy. The trial is currently recruiting participants aged 18 to 75 who have experienced a spinal cord injury within the last 12 to 30 months and have specific strength scores indicating some ability to move.

To participate, individuals must be medically stable and capable of following directions during therapy sessions. They should also have a certain level of shoulder movement to take part in the upper limb tasks involved in the study. It’s important to note that those with certain conditions, such as severe pain or excessive muscle tightness, or those who have recently received specific treatments or medications, may not be eligible. If you or a loved one qualifies, you can expect to engage in physical therapy along with the EMF treatment, and your involvement will help researchers better understand this potential new therapy for spinal cord injuries.

Gender

ALL

Eligibility 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