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Neurostimulation in Chronic and Episodic Migraine

This study is currently recruiting participants.
Verified October 2016 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT03237754
First Posted: August 3, 2017
Last Update Posted: August 3, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Kantonsspital Baden
Information provided by (Responsible Party):
University of Zurich
  Purpose
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 Intervention
Double-blind Design Sham-controlled Randomized Device: tDCS device from neuroConn

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

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

  • 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


Estimated Enrollment: 150
Actual Study Start Date: October 1, 2016
Estimated Study Completion Date: December 30, 2019
Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03237754


Contacts
Contact: Lars Michels, PhD +41442554965 lars.michels@usz.ch
Contact: Spyros Kollias, Prof. +41442555600 spyros.kollias@usz.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Lars Michels, PhD    +41 44 255 4965    lars.michels@usz.ch   
Contact: Spyros Kollias, Prof    +41 44 255 5600    spyros.kollias@usz.ch   
Principal Investigator: Lars Michels, PhD         
Sponsors and Collaborators
University of Zurich
Kantonsspital Baden
Investigators
Principal Investigator: Lars Michels, PhD University of Zurich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03237754     History of Changes
Other Study ID Numbers: 2016-00646
First Submitted: July 28, 2017
First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
migraine
neurostimulation
neuroimaging
tDCS
MRI

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases


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