Double-blind Design, Randomized, Sham-controlled
Conditions
Keywords
migraine, neurostimulation, neuroimaging, tDCS, MRI
Brief summary
Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic) drug therapy. In contrast, neurophysiologically guided treatments might provide an alternative avenue, since these can normalize brain alterations without side effects. Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic treatment of migraine, probably because of its modifying and re-balancing influence on neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it is necessary to apply not only tDCS but also a sham placebo, which is often neglected in tDCS stimulation studies. Further, tDCS needs to be applied in a large (n \> 20) sample of well-defined migraine patients, which would be advantageous, compared to previously published work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS is essential to investigate physiological mechanisms of tDCS. There is an increasing interest towards non-pharmacological treatment alternatives for migraine (and headache disorders) with reduced side effects to established prophylactic medications. The primary outcome of this project is to demonstrate that repetitive sessions of neurostimulation lead to a significant and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays accepted as therapeutic tools, our study might provide evidence that tDCS can be a non-pharmacological alternative for treating migraine.
Interventions
DEVICEtDCS device from neuroConn
weak electrical direct current stimulation
Sponsors
Kantonsspital Baden
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Intervention model description
Patients receive either Placebo or real neurostimulation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Patients from age 18 upwards (max. 80 years) suffering from chronic or episodic migraine. Medication overuse headache (MOH) patients are included as well (as chronic migraine patients do often show MOH). Healthy volunteers (18-80 years) are included if they don't fulfil the
Exclusion criteria
and do not suffer from migraine or other headache disorders, except infrequent episodic tension-type headache All volunteers are able to read and sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine days | 6 months | Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MR data | 6 months | Changes in functional and structural MR data before and after tDCS Treatment |
| Clinical data | 6 months | Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable migraine days |
Countries
Switzerland
Outcome results
None listed