Clinical trial NCT03237754: Neurostimulation in Chronic and Episodic Migraine
Official title: Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Double-blind Design
Sham-controlled
Randomized
Keywords: migraine
neurostimulation
neuroimaging
tDCS
MRI
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Kantonsspital Baden
First posted: 2017-08-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients receive either Placebo or real neurostimulation
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Migraine days
timeFrame: 6 months
Secondary outcomes:
measure: MR data
timeFrame: 6 months
measure: Clinical data
timeFrame: 6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Lars Michels, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schading S, Pohl H, Gantenbein A, Luechinger R, Sandor P, Riederer F, Freund P, Michels L. Tracking tDCS induced grey matter changes in episodic migraine: a randomized controlled trial. J Headache Pain. 2021 Nov 20;22(1):139. doi: 10.1186/s10194-021-01347-y.