G43
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
LMU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner