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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237754
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
Kantonsspital Baden
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE July 28, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE October 1, 2016
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03237754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurostimulation in Chronic and Episodic Migraine
Official Title  ICMJE Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Double-blind Design
  • Sham-controlled
  • Randomized
Intervention  ICMJE Device: tDCS device from neuroConn
weak electrical direct current stimulation
Study Arms  ICMJE
  • Experimental: Real Neurostimulation
    4 weeks of neurostimulation (using tDCS)
    Intervention: Device: tDCS device from neuroConn
  • Sham Comparator: Sham Neurostimulation
    4 weeks of sham Treatment with the same device used for real neurostimulation
    Intervention: Device: tDCS device from neuroConn
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lars Michels, PhD +41442554965 lars.michels@usz.ch
Contact: Spyros Kollias, Prof. +41442555600 spyros.kollias@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03237754
Other Study ID Numbers  ICMJE 2016-00646
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Kantonsspital Baden
Investigators  ICMJE
Principal Investigator: Lars Michels, PhD University of Zurich
PRS Account University of Zurich
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP