eurorehabilitation by EEG-Controlled Magnetic Stimulatio
- Conditions
- Stroke patients with a severely paralyzed legI63.9Cerebral infarction, unspecified
- Registration Number
- DRKS00023814
- 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
- 12
Healthy participants
1. Subject is aged between 18 and 60 years
2. Subject is in good physical and mental health.
3. Subject understands the study procedures and risks, and agrees to participate
in the study by giving written informed consent
4. Subject is willing to comply with the study restrictions
Stroke patients
1.Subject is aged between 18 and 80 years
2.Subject understands the study procedures and agrees to participate in the study by giving written informed consent
3.Subject is willing to comply with the study restrictions
4.Subject had an ischemic or hemorrhagic apoplexy with a subcortical lesion (Marklager, capsula interna, pedunculi cerebri)
5.Subject has a substantial motoric deficit. (Medical Research Council Score of less than 2)
6.Subject has realistic expectations of the personal gain in mobility through the participation in this study.
7.Subject has the means and intentions to stay available for inventions over the course of the study.
8.Paralysis of one leg
9.Time since stroke of at least 6 months (chronic stage)
10.Subject has no additional diseases such as tumors, severe cardiac insufficiency or cardiac arrhythmia
11.Subject has no psychiatric or neurological condition other than stroke
12.Subject has no depression
13.Subject is not pregnant
14.Subject has no epilepsy or medication for epilepsy during the last 6 months
15.Subject has no metallic implants in the body
16.Subject did not receive Botox treatment during the last 3 months
17.Subject is able to understand and follow instructions
Healthy participants
1. Subject is under the age of legal consent.
2. Subject is mentally or legally incapacitated, has significant emotional
problems or has a history of a clinically significant psychiatric disorder over
the last 5 to 10 years.
3. Subject is suffering a severe internistic, neurological or psychiatric disorder.
4. Subject has a history of any illness that, in the opinion of the study
investigator, might confound the results of the study or poses an additional
risk to the subject by their participation in the study.
6. Subject has a history of stroke, seizures, or major neurological disorder.
7. Subject has a history of significant head injury/trauma
8. Subject has a family history of epilepsy.
9. Subject has a cardiac pacemaker, implanted medication pump, intracardiac
line, or acute, unstable cardiac disease.
10.Subject has an intracranial implant (e.g., aneurysm clips, shunts, stimulators,
cochlear implants, or electrodes) or any other metal object within or near the
head (excluding the mouth) that cannot be safely removed.
Stroke patients
1. Subject is under the age of legal consent
2. Subject is mentally or legally incapacitated, has significant emotional problems or has a history of a clinically significant psychiatric disorder (including poststroke depression) over the last 5 to 10 years. Subjects who have had a stroke-unrelated situational depression may be enrolled in the study at the discretion of the investigator.
3. Subject has significant and uncontrollable medical conditions (severe coronal disorders, cardiac insufficiency (NYHA Degree IIIIV), severe arrhythmia, edema of high degree, malign tumors or terminal kidney failure.
4. Subject has a lesion in the cerebellum.
6. Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
7. Subject has a family history of epilepsy.
8. Subject has a cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstable cardiac disease.
9. Subject has an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.
10.Subject consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.
11.Subject is currently a regular user (including recreational use”) of any illicit drugs or has a history of drug (including alcohol) abuse.
12.Subject has participated in another clinical trial within 4 weeks prior to the first study visit.
13.There is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason; the investigator considers the subject inappropriate for participation in the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A physiotherapist will carry out the following measures one day before and one day after the intervention completion:<br>- Fugl-Meyer Assessment (FMA): a stroke-specific, performance-based impairment index.<br>- Modified Ashworth scale: measurement of spasticity and resistance to stretching<br>- Behavioral assessments: 10-meter walk test, 2-minute walk test, time up&go test<br>
- Secondary Outcome Measures
Name Time Method The following assessments for synaptic efficacy will be measured before, during and after intervention:<br>- Motor Evoked Potentials (MEPs): brain to muscle efferent connectivity using magnetic stimulation.<br>- Trans-spinal Motor Evoked Potentials (ts-MEPs): spine to muscle efferent connectivity using magnetic stimulation.<br>- Somatosensory Evoked Potentials (SEPs): muscle to brain afferent using electrical stimulation.<br>- Trans-spinal Somatosensory Evoked Potentials (ts-SEPs): spine to brain afferent connectivity using electrical stimulation.<br>- H-reflexes: spinal excitability involving afferent and efferent connectivity from the muscle using electrical stimulation.<br>- Electromyography data will be acquired on both legs (healthy and paretic) to assess muscle function<br>- Electroencephalography data to assess brain activity changes<br>- Kinematics data will be video-recorded and markers placed on anatomical landmarks will be used to assess the range of motion<br>