Status:
UNKNOWN
The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients
Lead Sponsor:
BrainQ Technologies Ltd.
Collaborating Sponsors:
The Miami Project to Cure Paralysis
Sheba Medical Center
Conditions:
Incomplete Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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, Sens...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04050696
Start Date
September 18 2019
End Date
February 1 2024
Last Update
August 22 2023
Active Locations (3)
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1
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
2
Kessler Institute of Rehabilitation
West Orange, New Jersey, United States, 07052
3
Sheba Medical Center
Ramat Gan, Israel