DRKS00013926招募中未知

Hybrid brain-machine interface (hBMI) for motor function restoration of the upper limb in chronic stroke patients.

Institute of Medical Psychology and Behavioral Neurobiology. University of Tübingen0 个研究点目标入组 16 人开始时间: 2018年2月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Ischemic or hemorrhagic stroke with subcortical damage and, if possible, intact motor cortex.
•2. Considerable motor impairment in the upper-limb, with MRC (Medical Research Council) below 2 out of 5 (0 = no movement; 1 = only a trace or flicker of movement is seen or felt, or muscle twitching/spasms (fasciculations) are observed; 2 = muscle can only move if resistance of gravity is removed; 3 = strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed; 4 = reduced strength, but contraction can still move joint against resistance; 5 = muscle contraction against full resistance, normal;).
•3. Paralysis of one hand with no residual active finger extension
•4. Time since stroke of at least 6 months (chronic stage)
•5. Age 18 to 80.
•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

•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)

发起方

Institute of Medical Psychology and Behavioral Neurobiology. University of Tübingen