NCT03237754

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

3.7 years

First QC Date

July 28, 2017

Last Update Submit

August 26, 2020

Conditions

Double-blind DesignSham-controlledRandomized

Keywords

migraineneurostimulationneuroimagingtDCSMRI

Outcome Measures

Primary Outcomes (1)

  • Migraine days

    Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group

    6 months

Secondary Outcomes (2)

  • MR data

    6 months

  • Clinical data

    6 months

Study Arms (2)

Real Neurostimulation

EXPERIMENTAL

4 weeks of neurostimulation (using tDCS)

Device: tDCS device from neuroConn

Sham Neurostimulation

SHAM COMPARATOR

4 weeks of sham Treatment with the same device used for real neurostimulation

Device: tDCS device from neuroConn

Interventions

tDCS device from neuroConnDEVICE

weak electrical direct current stimulation

Real NeurostimulationSham Neurostimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Pohl H, Sandor PS, Moisa M, Ruff CC, Schoenen J, Luechinger R, O'Gorman R, Riederer F, Gantenbein AR, Michels L. Occipital transcranial direct current stimulation in episodic migraine patients: effect on cerebral perfusion. Sci Rep. 2023 Aug 25;13(1):13944. doi: 10.1038/s41598-023-39659-5.

    PMID: 37626074DERIVED

  • 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.

    PMID: 34800989DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Lars Michels, PhD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Patients receive either Placebo or real neurostimulation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 3, 2017

Study Start

October 1, 2016

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations

CH(1)