The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients
NCT ID: NCT04050696
Last Updated: 2023-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
8 participants
INTERVENTIONAL
2019-09-18
2024-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (with PT run-in)
Treatment group, to receive BQ treatment with PT, after stability established in 4 week PT run-in period
BQ 1.2
BQ 1.2 exposure of EMF exposure paradigm in conjunction with upper limb PT regimen
Interventions
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BQ 1.2
BQ 1.2 exposure of EMF exposure paradigm in conjunction with upper limb PT regimen
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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The Miami Project to Cure Paralysis
OTHER
Sheba Medical Center
OTHER_GOV
Kessler Institute for Rehabilitation
INDUSTRY
BrainQ Technologies Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Gabi Zeilig, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Dalton Dietrich, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Miami Project to Cure Paralysis
Ghaith Androwis, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kessler Institute of Rehabilitation
Locations
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The Miami Project to Cure Paralysis
Miami, Florida, United States
Kessler Institute of Rehabilitation
West Orange, New Jersey, United States
Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BQ4
Identifier Type: -
Identifier Source: org_study_id
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