ISRCTN10150672暂停未知
A neurorehabilitation therapy based on a brain machine interface (BMI) for the motor function restoration of the upper limb in chronic stroke patients: Intracranial Stroke MOtor REhabilitation
Instituto de Investigación Sanitaria Biodonostia (Spain)0 个研究点目标入组 6 人开始时间: 2015年5月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Assessment of physical and psychological function and impairment:
- •1. Wolf-Motor test
- •2. Goal Attainment Scale (GAS)
- •3. Motor Activity Log
- •4. KVIQ-20
- •5. Modified Ashworth scales (spasticity)
- •6. Beck Depression Inventory (BDI)
- •7. Hamilton Depression Rating Scale (HDRS)
- •8. Berlin Social Support Scale (BSSS)
- •9. The Schedule for the Evaluation of the Individual Quality of Life-Direct Weighting (SEIQoL-DW) (quality of life)
- •10. Placebo Questionnaire
- •Patients will be selected according to strict inclusion criteria, including but not limited to their level of impairment, physiology of the stroke lesion, psychological and cognitive characteristics.
- •All participants should fulfill the following criteria:
- •1. Paralysis of one hand with no residual active finger extension
- •2. Considerable motor impairment in the upper-limb, with MRC (Medical Research Council) below 2 out of 5 (5 = muscle contraction against full resistance, normal; 4 = reduced strength, but contraction can still move joint against resistance; 3 = strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed; 2 = muscle can only move if resistance of gravity is removed; 1 = only a trace or flicker of movement is seen or felt, or muscle twitching/spasms (fasciculations) are observed; 0 = no movement).
- •3. Ischemic or hemorrhagic stroke with subcortical damage and, if possible, intact motor cortex.
- •4. Time since stroke of at least 9 months (chronic stage)
- •5. Age 18 to 70
- •6. No psychiatric or neurological condition other than stroke
- •7. No cerebellar lesion or bilateral motor deficit
- •8. No pregnancy
- •9. No claustrophobia
- •10. No epilepsy or medication for epilepsy during the last 6 months
- •11. Eligibility to undergo magnetic resonance imaging (MRI)
- •12. Ability to understand and follow instructions
排除标准
- •1. Drug and/or alcohol abuse
- •2. Psychiatric disorder (including post-stroke depression)
- •3. Cerebellar damage
- •4. Bilateral motor deficit
- •5. Uncontrolled health problems (coronary heart disease, severe heart failure in stage III-IV according to NYHA, severe cardiac arrhythmia, severe edema, severe arthritis, malignant tumor, chronic renal failure)
- •6. Cognitive impairment (Mini Mental State below 23/30 points). Patients with cognitive or language difficulties that will prevent them giving informed consent and/or follow instructions
- •7. Pregnancy
- •8. Drug-resistant epilepsy
- •9. Pacemakers, metallic implants (ferromagnetic) or claustrophobia, contraindications to undergo magnetic resonance imaging (MRI)
研究者
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