The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients (NCT04050696) | Clinical Trial Compass
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The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients
United States, Israel8 participantsStarted 2019-09-18
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males and non-pregnant females who are between 18 to 75 years of age
✓. Diagnosed with traumatic or (incident-related) non-traumatic chronic cervical incomplete SCI (AIS B-D), 12 to 30 months from event.
✓. Individuals with a score between 5 - 35 on the GRASSP strength subscore on at least one side
✓. Medically stable
✓. 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)
✓. Stable pharmacological treatment plan without any planned modifications
✓. Able to engage in physical therapy program as stipulated per protocol
✓. 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
Exclusion criteria
✕. Excessive pain in the UE that limits the administration of the evaluation measurements
✕. Excessive spasticity: subjects with MAS of wrist ≥ 2, or MAS of elbow ≥ 3
✕. Received botulinum toxin in the previous 4 months, or planning of an upcoming injection during the trial period
✕. Participating in any other experimental rehabilitation or drug studies
What they're measuring
1
Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore):