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Neurostimulation in Chronic and Episodic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03237754
Recruitment Status : Terminated (Recruitment problems (especially for chronic migraine patients))
First Posted : August 3, 2017
Last Update Posted : August 28, 2020
Kantonsspital Baden
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Double-blind Design Sham-controlled Randomized Device: tDCS device from neuroConn Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients receive either Placebo or real neurostimulation
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Basic Science
Official Title: Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 30, 2020
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Real Neurostimulation
4 weeks of neurostimulation (using tDCS)
Device: tDCS device from neuroConn
weak electrical direct current stimulation

Sham Comparator: Sham Neurostimulation
4 weeks of sham Treatment with the same device used for real neurostimulation
Device: tDCS device from neuroConn
weak electrical direct current stimulation

Primary Outcome Measures :
  1. Migraine days [ Time Frame: 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 :
  1. MR data [ Time Frame: 6 months ]
    Changes in functional and structural MR data before and after tDCS Treatment

  2. Clinical data [ Time Frame: 6 months ]
    Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable "migraine days

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03237754

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University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Kantonsspital Baden
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Principal Investigator: Lars Michels, PhD University of Zurich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Zurich Identifier: NCT03237754    
Other Study ID Numbers: 2016-00646
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases