Neurostimulation in Chronic and Episodic Migraine

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation

Conditions
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Double-blind Design, Sham-controlled, Randomized

Intervention / Treatment
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* Device: tDCS device from neuroConn


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Patients and healthy volunteers are excluded if they fulfil one of the following exclusion criteria: Common MR exclusion criteria: such as metallic items in the body (i.e. eye splinter, MR incompatible implants*), pacemaker, claustrophobia or obesity (body mass index > 35). Also pregnant participants and participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease will be excluded. Participants with major psychiatric disorders such as schizophrenia, bipolar disorder will also be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients receive either Placebo or real neurostimulation
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real Neurostimulation<br>4 weeks of neurostimulation (using tDCS) | Device: tDCS device from neuroConn<br>* weak electrical direct current stimulation<br>|
| Sham Comparator: Sham Neurostimulation<br>4 weeks of sham Treatment with the same device used for real neurostimulation | Device: tDCS device from neuroConn<br>* weak electrical direct current stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine days | Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MR data | Changes in functional and structural MR data before and after tDCS Treatment | 6 months | 
| Clinical data | Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable migraine days | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, neurostimulation, neuroimaging, tDCS, MRI