The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Fugl Meyer Assessment of Upper Extremity (FMA-UE)
研究概览
简要总结
The study tests the efficacy of a non-invasive device with low intensity electromagnetic field dedicated treatment to enhance the recovery of stroke patients impaired hand motor function
详细描述
The study investigates the effect of BCI based stimulation device on upper limb motor function of acute stroke patients.
The BQ device (BrainQ Technologies Ltd., Israel), a Brain Computer Interface based stimulation device, uses machine learning tools to identify high resolution spectral patterns associated with motor functions in EEG measurements of healthy/non healthy subjects. These patterns are then translated into a tailored frequency dependent low intensity, non-invasive electro-magnetic treatment protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sham device appears as real device. Only randomizer which is a third party, is unblinded. First 4 patients are non randomized
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of 1st ever ischemic stroke confirmed by imaging or 1st recurrent ischemic stroke with no previous neurological impairment in the same limb before current stroke happened
- •72h to 15 days from stroke onset or 21 days from stroke onset in case the patient was still unstable at day 15 from stroke onset).
- •Medically stable patients
- •Age: > 18, <80 years, and independent in their daily activities before the stroke
- •Right dominant hand
- •FM >10, <45 of upper tested limb.
- •Able to sit in a chair for 70 consecutive minutes and follow three verbal instructions:
- •Bring your healthy arm to the level of your shoulder
- •Pick up this pen with your healthy hand.
- •Put your healthy hand on your waist
- •Able to understand the information provided and provide informed consent
排除标准
- •Contraindication for performing MRI scanning
- •History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold
- •Patients with an acute problem such as active infection at the time of recruitment for research
- •Previous disease of the central nervous system
- •Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested
- •Patients known to suffer from some peripheral nerve damage of the upper limb that being tested
- •Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
- •Alcoholism or drug addiction as defined by DSM-IV within last 5 years
研究组 & 干预措施
Treatment group
Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks.
干预措施: BQ (Device)
Control group
Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks.
干预措施: Sham (Device)
结局指标
主要结局
Fugl Meyer Assessment of Upper Extremity (FMA-UE)
时间窗: Two months
FMA score of upper limb, range between 0 to 66 (higher the better)
次要结局
- NIHSS(two months)
- MoCA(two months)
- MRI-DTI(two months)
- brain recovery biomarkers(two months)
- TMT(two months)
- BBT(two months)
- Promis 10(two months)
- mRs(two months)
- ARAT(two months)