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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Incomplete Spinal Cord Injury
- Sponsor
- BrainQ Technologies Ltd.
- Enrollment
- 8
- Locations
- 3
- Primary Endpoint
- Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore):
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore):
Time Frame: Week 22
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)
Secondary Outcomes
- Capabilities of the Upper Extremity Test (CUE-T)(Week 1, week 5, week 22)
- 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)
- GRASSP (strength subscores)(Week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34)
- Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI) scans(Week 5, week 22)
- GRASSP (sensibility and prehension subscores)(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)
- Questionnaire of von Korff et al. Grading the Severity of Chronic Pain(Week 1, week 5, week 22)
- The Spinal Cord Injury-Quality of Life (SCI-QOL)(Week 1, week 5, week 22)