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

The purpose of this study is to further establish safety and efficacy of the BQ EMF treatment of chronic SCI subjects who demonstrate stability in The Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) strength score following a one-month physical therapy run-in period.

BQ is a brain-computer interface (BCI) based medical device that produces and delivers non-invasive, low intensity and low frequency electromagnetic fields targeting a patient's central nervous system (CNS) for motor rehabilitation. The technology behind the device utilizes machine learning (ML) tools to identify high-resolution spectral patterns, which characterize motor functions within EEG and MEG/EMG measurements taken during functional motor tasks. These patterns are then translated into a frequency-dependent, low intensity and non-invasive electromagnetic treatment, which applies similar patterns directly to a patient's CNS.

BQ treatment is intended to improve upper limb motor function of chronic SCI patients, over 18 years of age with an incomplete injury and upper limb motor impairment (AIS B - D, Cervical C1 - C8). The treatment will be administered as an adjunctive treatment along with a typical pharmacological and/or non-pharmacological treatment plan.

Study is a prospective, single arm, multicenter study with physical therapy (PT) run-in phase, where each subject serves as his/her own control. Study population will include at least 8 individuals with traumatic or (incident-related) non-traumatic chronic cervical incomplete SCI (AIS B-D) who are 12 - 30 months post-injury, with score between 5 - 35 on GRASSP strength subscore on at least one side, and medically stable.

The primary objective of this study is to evaluate the efficacy of the BQ system treatment in improving upper limb motor function of chronic SCI subjects, compared to their own baseline after stability has been demonstrated during physical therapy run-in period, as measured by improvement in GRASSP strength subscore. An additional secondary objective of the study is to evaluate the efficacy of the BQ system treatment in improving motor recovery, spasticity, pain, QOL, and imaging outcomes in the stated population.

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