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

Description

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.

Conditions

Incomplete Spinal Cord Injury

Study Overview

Study Details

Study overview

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.

The Safety and Efficacy of the Use of a Brain-computer Interface-based Electromagnetic Field Treatment in the Management of Chronic SCI Patients - a Pilot Study

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

Condition
Incomplete Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

Miami

The Miami Project to Cure Paralysis, Miami, Florida, United States, 33136

West Orange

Kessler Institute of Rehabilitation, West Orange, New Jersey, United States, 07052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BrainQ Technologies Ltd.,

Gabi Zeilig, Ph.D., PRINCIPAL_INVESTIGATOR, Sheba Medical Center

Dalton Dietrich, Ph.D., PRINCIPAL_INVESTIGATOR, The Miami Project to Cure Paralysis

Ghaith Androwis, Ph.D., PRINCIPAL_INVESTIGATOR, Kessler Institute of Rehabilitation

Study Record Dates

2024-02-01