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

NCT04050696 | Unknown FDA Device

• 1 other identifier: BQ4
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 3

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, Sensibility and Prehension (GRASSP) strength score following a one-month physical therapy run-in period.

Conditions

Incomplete Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore):

  The GRASSP is a clinical measure of upper limb impairment, which incorporates the construct of upper limb sensorimotor function. This measurement captures information on upper limb sensorimotor impairment for individuals with tetraplegia and defines neurological status with numerical values, which represent the deficits in a predictive pattern. The GRASSP demonstrates reliability, construct validity, and concurrent validity for use as a standardized upper limb impairment measure for individuals with incomplete SCI (Kalsi-Ryan et al., 2012). Scores can be used to determine relationships between impairment and functional capability of the upper limb. The evaluation includes three domains of hand function: 1. Strength (primary) 2. Sensibility (secondary) 3. Prehension (secondary) For the primary outcome measure, only the strength subscore will be assessed as follows: ● Strength (10 muscles of arm \& hand): motor grade 0-5 for each (sum = subtest total, 0-50)

  Week 22

Secondary Outcomes (9)

• GRASSP (strength subscores)

  Week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34

• GRASSP (sensibility and prehension subscores)

  Week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34

• ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury)

  Week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34

• Modified Ashworth Scale (MAS)

  Week -1, week 1, week 5, week 22

• Spinal Cord Independence Measure III (SCIM III - self-care sub-score)

  Week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34

Other Outcomes (7)

• Surface EEG

  Week 1, week 5, week 9, week 14, week 18, week 22, week 26

• Surface EMG

  Week 1, week 5, week 9, week 14, week 18, week 22, week 26

• Smoothness of reaching movement

  Week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34

Study Arms (1)

Treatment (with PT run-in)

EXPERIMENTAL

Treatment group, to receive BQ treatment with PT, after stability established in 4 week PT run-in period

Device: BQ 1.2

Interventions

BQ 1.2 DEVICE

BQ 1.2 exposure of EMF exposure paradigm in conjunction with upper limb PT regimen

Treatment (with PT run-in)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• BrainQ Technologies Ltd.: lead
• The Miami Project to Cure Paralysis: collaborator
• Sheba Medical Center: collaborator
• Kessler Institute for Rehabilitation: collaborator

Study Sites (3)

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

RECRUITING

Kessler Institute of Rehabilitation

West Orange, New Jersey, 07052, United States

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Central Cord Syndrome; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabi Zeilig, Ph.D.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Dalton Dietrich, Ph.D.

  The Miami Project to Cure Paralysis

  PRINCIPAL INVESTIGATOR

• Ghaith Androwis, Ph.D.

  Kessler Institute of Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assaf Lifshitz

CONTACT

+972-54-4586787; assaf@brainqtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Treatment-only study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 8, 2019
• Study Start: September 18, 2019
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IL (1)