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

Status unconfirmed · Not applicable

Conditions studied: Incomplete Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT04050696

Run by

BrainQ Technologies Ltd.

People needed

8

Starts

2019-09-18

Expected to finish

2024-02-01

Last updated by the study team

2023-08-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Negative pregnancy test in women of childbearing potential
• 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

You may not qualify if…

• Subjects not eligible for this study include those that have any of the following:
• 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
• Medical conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation
• Severe cognitive or psychiatric problems that might significantly impact the successful study conduct
• History of epileptic seizures or epilepsy
• Implanted electronic medical devices
• Alcoholism or drug addiction as defined by DSM-IV within last 5 years

Where it is running

• The Miami Project to Cure Paralysis — Miami, Florida, United States (enrolling)
• Kessler Institute of Rehabilitation — West Orange, New Jersey, United States (enrolling)
• Sheba Medical Center — Ramat Gan, Israel (enrolling)

Full record on ClinicalTrials.gov

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