Clinical trial NCT04050696: The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: BrainQ Technologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Miami Project to Cure Paralysis
name: Sheba Medical Center
name: Kessler Institute for Rehabilitation
First posted: 2019-08-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 (CNS) for motor rehabilitation. The technology behind the device utilizes machine learning (ML) tools to identify high-resolution spectral patterns, which characterize motor functions within EEG and MEG/EMG measurements taken during functional motor tasks. These patterns are then translated into a frequency-dependent, low intensity and non-invasive electromagnetic treatment, which applies similar patterns directly to a patient's CNS.

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.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

Subjects not eligible for this study include those that have any of the following:

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

Primary outcomes:
measure: Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore):
timeFrame: Week 22
Secondary outcomes:
measure: GRASSP (strength subscores)
timeFrame: Week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
measure: GRASSP (sensibility and prehension subscores)
timeFrame: Week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
measure: ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury)
timeFrame: Week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
measure: Modified Ashworth Scale (MAS)
timeFrame: Week -1, week 1, week 5, week 22
measure: Spinal Cord Independence Measure III (SCIM III - self-care sub-score)
timeFrame: Week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
measure: Questionnaire of von Korff et al. Grading the Severity of Chronic Pain
timeFrame: Week 1, week 5, week 22
measure: Capabilities of the Upper Extremity Test (CUE-T)
timeFrame: Week 1, week 5, week 22
measure: The Spinal Cord Injury-Quality of Life (SCI-QOL)
timeFrame: Week 1, week 5, week 22
measure: Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI) scans
timeFrame: Week 5, week 22
Other outcomes:
measure: Surface EEG
timeFrame: Week 1, week 5, week 9, week 14, week 18, week 22, week 26
measure: Surface EMG
timeFrame: Week 1, week 5, week 9, week 14, week 18, week 22, week 26
measure: Smoothness of reaching movement
timeFrame: Week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
measure: Range of motion (ROM)
timeFrame: Week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
measure: Venous blood collection
timeFrame: Week 1, week 5, week 22
measure: Assessment of device's Usability by user (Human factors and usability analysis)
timeFrame: Week 0 of 1st patient, week 22 of 2nd patient, week 34 of 4th patient
measure: Rate of deviation of device user from expected input sequence (Human factors and usability analysis)
timeFrame: Week 34 of 4th patient
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
city: West Orange
country: United States
facility: Kessler Institute of Rehabilitation
state: New Jersey
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Gabi Zeilig, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miami Project to Cure Paralysis
name: Dalton Dietrich, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kessler Institute of Rehabilitation
name: Ghaith Androwis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: