Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Spine
Enrollment Eligibility
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