G81.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy Subjects • written informed consent form • Healthy subjects without any chronic disorder Patients • written informed consent form • Patients with bilateral spastic cerebral palsy or unilateral spastic cerebralpalsy or hemiaparesis caused by acquired brain injury if both of the following criteria are met: - Weakness of ankle dorsalflexors (muscle function score = 3 on the Medical Research Council Scale) - The "chronic state" of the disability (brain injury at least 5 years ago)
Exclusion criteria
Exclusion criteria: • Current treatment with botulinum toxin • Orthopedic surgery of the lower extremity within the last 12 months • Implanted ferromagnetic material in the lower extremity • Contraindications for the application of magnetic stimulation or MRI imaging: - Diagnosis of epilepsy - Ferromagnetic implant / biomedical device (e.g., cochlear implant, pacemaker, vagus nerve stimulator, ventriculo-peritoneal shunt) - Pregnancy - Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Are there effects on cortical excitability measured by nTMS (changes in MEP-amplitude) at d+1 (1 day after rNMS treatment) compared to T0 (baseline)? | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Are there clinical significant effects measured by SCALE, ROM, MRSC, Dynam, Spast) at d+1 and d+7 compared to T0. 2. Are there effects on cortical excitability measured by nTMS (changes in MEP-latency and MEP-recruitment curve) at d1 compared to T0. 3. Are there effects on cortical excitability measured by nTMS (changes in MEP-amplitude, MEP-latency, MEP-recruitment curve and resting-motor threshold) at S1, S6, S12 and d7 compared to T0. 4. Are there effects on cortical excitability measured by nTMS (changes in intracortical faciliation, short-interval intracortical inhibition, and ipsilateral silent period) at d1 and d7 compared to T0. 5. How does the motor area measured by nTMS motor mapping change at d+1 and d+7 compared to T0. 6. How does the muscle structure (echogenicity, gray value comparison), the cross-sectional area, the muscle volume, the length of the muscle-sync unit and the fascia length as well as the pennation angle in muscle ultrasound change at S1, S6, S12, d+1 and d+7 compared to T0. 7. How do muscle volume, muscle cross-sectional area, muscle composition and microstructural architecture as well as the innervation profile in muscle MRI using T1-weighted sequences, T2 mapping, chemical shift-encoded water-fat (CSE) and diffusion-weighted sequences change at d+1 and d+7 compared to T0. 8. How does the cerebral perfusion change, represented by pseudo-continuous arterial spin labeling (pCASL) sequence at d+1 and d+7 compared to T0. 9. How do the volume, integrity, and microstructure of the corticospinal tract (CST) and interhemispheric fibers in tractography (MRI with diffusion-weighted sequence acquisition (DTI)) change at d+1 and d+7 compared to T0. 10. Regarding the detection of the target muscle and the area with a high number of motor endplates in 3D ultrasound: Verification of reproducibility by test-retest and parallel-test reliability. | — |
Countries
Germany
Contacts
LMU Klinikum München, Dr. von Haunerschen Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner