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
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore):
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Treatment-only study
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (with PT run-in)
Treatment group, to receive BQ treatment with PT, after stability established in 4 week PT run-in period
干预措施: BQ 1.2 (Device)
结局指标
主要结局
Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore):
时间窗: 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)
次要结局
- 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)