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Neuromodulation via repetitive peripheral magnetic stimulation (rPMS) in children and adolescents with migraine - feasibility and acceptance of rPMS as novel therapy option in neuropediatrics

Neuromodulation via repetitive peripheral magnetic stimulation (rPMS) in children and adolescents with migraine - feasibility and acceptance of rPMS as novel therapy option in neuropediatrics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022141
Enrollment
15
Registered
2020-06-25
Start date
2020-08-11
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

G43

Interventions

Group 1: Each patient will receive 6 rPMS therapy sessions within 2-3 weeks. Each session consists of the following: anamnesis, recording of adverse events from the previous therapy session, rPMS ther

Sponsors

LMU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner, München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Written informed consent from the caregivers - Written informed consent from the children/adolescents - Age between 6 and 17 years (up to the age of 18) - At least one myofascial trigger point in the pars descendens of ??the trapezius muscle (determined by the child neurologist/physiotherapist) - Migraines according to the ICHD 3 criteria

Exclusion criteria

Exclusion criteria: - Familial hemiplegic migraine - Current use of pharmaceutical migraine prophylaxis, other than magnesium supplements - Other neurological/psychiatric conditions - Other serious illnesses (e.g. malignant illness, chronic inflammatory illness) - Contraindications for magnetic stimulation treatment: diagnosis of epilepsy; metal on or in the body, e.g. piercings, intrauterine spiral, vascular clips; Implanted shunt systems (VP, VA, etc.; magnetically adjustable valve); Implanted biomedical devices (e.g. cochlear implant, medication pump, cardiac or brain pacemaker); pregnancy

Design outcomes

Primary

MeasureTime frame
How many patients take part in at least five out of six planned sessions over the entire duration of the individual treatment sessions (adherence rate)? The following sub-questions arise for the main question: If patients (child and caregivers) decide not to continue treatment - what is the reason for this? Would patients (child and caregivers) who successfully participated in the study for any reason not consider recommending rPMS as a possible therapy option to other patients?

Secondary

MeasureTime frame
• Efficacy: Exploratory evaluation of the clinical effect of the intervention • Recruitment rate: proportion of patients contacted who meet the inclusion criteria and actually participate in the study. • Safety: Recording of adverse events (AE) in self-created questionnaires; Evaluation of all recorded potential AEs with regard to causal connection with intervention; Classification of the severity of AEs • Satisfaction: of patients and caregivers with the intervention, acceptance of the rPMS treatment and motivation to continue the treatment using a self-created questionnaire • Assessment of the applicability from the physiotherapist's viewpoint: Individual assessment, including the practicability. Support for therapeutic treatment based on an interview guide/qualitative interview after the final examination

Countries

Germany

Contacts

Public ContactMichaela Bonfert

LMU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner

michaela.bonfert@med.uni-muenchen.de+49 (0)89 5527340

Outcome results

None listed

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