Hybrid brain-machine interface (hBMI) for motor function restoration of the upper limb in chronic stroke patients.
- Conditions
- Stroke patients with a severely paralysed armI63Cerebral infarction
- Registration Number
- DRKS00013926
- Lead Sponsor
- Institute of Medical Psychology and Behavioral Neurobiology. University of Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 16
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A physiotherapist will carry out the following measures on two different days before the intervention, immediately after intervention and six months after intervention completion:<br>- Fugl-Meyer Assessment (FMA): a stroke-specific, performance-based impairment index.<br>- Action Research Arm Test (ARAT): an evaluative measure to assess specific changes in limb function among individuals who have suffered a stroke. <br>- Polysomnography (PSG): a multi-parametric test used in the study of sleep.
- Secondary Outcome Measures
Name Time Method The following data will be acquired and analyzed for clinical assessment before and after intervention:<br>- Assessment of functional and structural changes in the brain due to intervention: functional and anatomical magnetic resonance imaging (fMRI and aMRI).<br>- Assessment of Motor Evoked Potentials (MEPs): Transcraneal Magnetic Stimulation (TMS).<br>- Functional stimulation amplitude needed to induce a muscle contraction (motor threshold) will be used to assess muscle fibers status<br><br>The following data will be acquired and analyzed for clinical assessment before, during and after intervention:<br>- Electromyography data will be acquired on both arms (healthy and paretic) to assess muscle function<br>- Electroencephalography data to assess brain activity changes<br>- Kinematics data will be obtained via exoskeleton sensors to assess motor performance and range of motion