Healthy subjects G43
Conditions
Interventions
Group 1: rPMS with 6000 stimuli per body side per treatment session
Group 2: sham stimulation
Group 3: rPMS with 3000 stimuli per body side per treatment session
Group 4: rPMS with intensities below t
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
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: All subjects: - Written informed consent - Age between 18 and 35 years Migraine patients: - Episodic migraine diagnosis since at least 6 months and based on the German version of the headache questionnaire modified according to the International Classification of Headache Disorders (3rd edition; ICHD-3; Essen headache questionnaire) - Episodic migraine: 15-45 headache days within the 3-month pre-interventional period (according to the DMKG headache calendar) - Pathological findings in the clinical manual examination of the trapezius muscle (e.g., in the form of generalized or localized tension, generalized or localized pressure pain, or active mTrP)
Exclusion criteria
Exclusion criteria: Migraine patients: - Familial hemiplegic migraine - Current use of a pharmacological migraine prophylaxis, apart from magnesium supplements (start at least 4 weeks before entering the baseline phase, documentation of changes in dosage during the study period necessary) - Previous / current treatment with magnetic stimulation (rPMS) All subjects: - Neurological illnesses (apart from migraine / migraine + tension headache in the migraine groups; apart from latent mTrP in the area of ??the trapezius muscle in healthy subjects) - Persistent chronic psychiatric illness (e.g., schizophrenia, personality disorders) and psychiatric illnesses currently requiring treatment (such as depression, anxiety or obsessive-compulsive disorder); a previous psychiatric illness whose treatment was completed less than 24 months ago (e.g., depressive episode, adjustment disorder) - Other serious illnesses (e.g. malignant illness, chronic inflammatory illness) - Contraindications for treatment or diagnostics with magnetic stimulation (rPMS, navigated transcranial magnetic stimulation (nTMS)): o Diagnosis of epilepsy o Metal on and in the body, e.g. piercings, intrauterine spiral, vascular clips o Implanted shunt systems (VP, VA, etc .; magnetically adjustable valve) o Implanted biomedical devices (e.g. cochlear implant, drug pump, heart or brain pacemaker) o Pregnancy - Contraindications for (functional) magnetic resonance imaging examinations (MRI, fMRI): o Metal on and in the body, e.g. piercings, intrauterine spiral o Implanted shunt systems (VP, VA, etc .; magnetically adjustable valve) o Implanted biomedical devices (e.g. cochlear implant, drug pump, heart or brain pacemaker) o Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| How does the frequency of headache days (documented in the DMKG headache calendar) 12 weeks after the rPMS treatment differ between the verum (6000 total stimuli) and the sham group (migraine patients)? Additional question: How does the frequency of headache days (documented in the DMKG headache calendar) differ 12 weeks after the rPMS treatment between all 4 treatment groups (migraine patients)? | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. How does the frequency of headache days change compared to the pre-interventional period in the 4 treatment groups (a) immediately after the rPMS intervention and (b) 12 weeks later, as documented in the DMKG headache calendar (migraine patients)? 2. How does the frequency of migraine days (as documented in the DMKG headache calendar) 12 weeks after rPMS treatment differ between group 1 (6000 total stimuli) and group 4 (sham group) (migraine patients)? 3. How does the frequency of migraine days (as documented in the DMKG headache calendar) 12 weeks after the rPMS treatment differ between all 4 treatment groups (migraine patients)? 4. How does the frequency of migraine days change compared to the pre-interventional period in the 4 treatment groups (a) immediately after the rPMS intervention and (b) 12 weeks later, as documented in the DMKG headache calendar (migraine patients)? 5. How high is the 50% responder rate (= proportion of patients for whom the reduction in migraine and headache days per month after treatment compared to baseline is at least 50%) in each of the 4 groups (migraine patients)? 6. How do intensity, duration, and clinical symptoms of the individual migraine and headache episodes as well as the associated medication change (a) immediately after the rPMS intervention and (b) 12 weeks later (migraine patients)? 7. How do impairment and quality of life change (a) immediately after the rPMS intervention and (b) 12 weeks later (migraine patients)? 8. How do depression and anxiety scores change (a) immediately after the rPMS intervention and (b) 12 weeks later (migraine patients)? 9. What influence do diet and lifestyle habits as well as stress and illness coping have on the rPMS intervention and how do the factors change 12 weeks after the intervention (migraine patients)? 10. How is the rPMS assessed (a) after each individual rPMS unit and (b) immediately after the rPMS intervention (tolerability, comfort, side effects) (all subjects)? 11 | — |
Countries
Germany
Contacts
Public ContactMichaela V. 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, München, Deutschland
Outcome results
None listed