Neurostimulation in Chronic and Episodic Migraine
- Conditions
- Double-blind DesignSham-controlledRandomized
- Interventions
- Device: tDCS device from neuroConn
- Registration Number
- NCT03237754
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real Neurostimulation tDCS device from neuroConn 4 weeks of neurostimulation (using tDCS) Sham Neurostimulation tDCS device from neuroConn 4 weeks of sham Treatment with the same device used for real neurostimulation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland