RECRUITING

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

Conditions

Incomplete Spinal Cord Injury chronic SCI incomplete SCI central cord syndrome electromagnetic field physical therapy cervical SCI paraplegia tetraplegia upper limb impairment GRASSP ISNCSCI

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-18

Study Completion:2024-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04050696

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Assaf Lifshitz

CONTACT

+972-54-4586787

assaf@brainqtech.com

Principal Investigator

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 Locations (Sites)

The Miami Project to Cure Paralysis

Miami, Florida, 33136

United States

Kessler Institute of Rehabilitation

West Orange, New Jersey, 07052

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-18

Study Completion Date2024-02-01

Study Record Updates

Study Start Date2019-09-18

Study Completion Date2024-02-01

Terms related to this study

Keywords Provided by Researchers

chronic SCI
incomplete SCI
central cord syndrome
electromagnetic field
physical therapy
cervical SCI
paraplegia
tetraplegia
upper limb impairment
GRASSP
ISNCSCI

Additional Relevant MeSH Terms

Incomplete Spinal Cord Injury