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TaNeMo Study: The physiological effects of repetitive neuromuscular magnetic stimulation (rNMS) as a basis for therapy target-adapted neuromodulation - the longitudinal trial [study period B]

TaNeMo Study: The physiological effects of repetitive neuromuscular magnetic stimulation (rNMS) as a basis for therapy target-adapted neuromodulation - the longitudinal trial [study period B] - TaNeMo - Longitudinal Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034714
Enrollment
60
Registered
2024-12-18
Start date
2024-05-05
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G81.1

Interventions

Group 1: During 3 weeks, healthy subjects will undergo 12 rNMS sessions targeting to the right anterior tibialis muscle to assess the extent and sustainability of rNMS-induced changes. Prior and after

Sponsors

LMU KLinikum, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie und Sozialpädiatrie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 30 Years

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

MeasureTime 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

MeasureTime 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

Public ContactMichaela Veronika Bonfert

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

michaela.bonfert@med.lmu.de+49 1525 4923717

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026