euromodulation via repetitive peripheral magnetic stimulation (rPMS) in children and adolescents with migraine - feasibility and acceptance of rPMS as novel therapy option in neuropediatrics
- Conditions
- G43Migraine
- Registration Number
- DRKS00022141
- Lead Sponsor
- MU Klinikum, Dr. von Haunersches Kinderspital, Abteilung für Pädiatrische Neurologie, Entwicklungsneurologie, Sozialpädiatrie und LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder - iSPZ Hauner, München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 14
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method • Efficacy: Exploratory evaluation of the clinical effect of the intervention<br><br>• Recruitment rate: proportion of patients contacted who meet the inclusion criteria and actually participate in the study.<br><br>• 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<br><br>• Satisfaction: of patients and caregivers with the intervention, acceptance of the rPMS treatment and motivation to continue the treatment using a self-created questionnaire<br><br>• 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