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Neurostimulation in Chronic and Episodic Migraine

Primary Purpose

Double-blind Design, Sham-controlled, Randomized

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
tDCS device from neuroConn
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Double-blind Design focused on measuring migraine, neurostimulation, neuroimaging, tDCS, MRI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real Neurostimulation

Sham Neurostimulation

Arm Description

4 weeks of neurostimulation (using tDCS)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MR data
Changes in functional and structural MR data before and after tDCS Treatment
Clinical data
Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable "migraine days

Full Information

First Posted
July 28, 2017
Last Updated
August 26, 2020
Sponsor
University of Zurich
Collaborators
Kantonsspital Baden
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1. Study Identification

Unique Protocol Identification Number
NCT03237754
Brief Title
Neurostimulation in Chronic and Episodic Migraine
Official Title
Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems (especially for chronic migraine patients)
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Kantonsspital Baden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Double-blind Design, Sham-controlled, Randomized
Keywords
migraine, neurostimulation, neuroimaging, tDCS, MRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients receive either Placebo or real neurostimulation
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real Neurostimulation
Arm Type
Experimental
Arm Description
4 weeks of neurostimulation (using tDCS)
Arm Title
Sham Neurostimulation
Arm Type
Sham Comparator
Arm Description
4 weeks of sham Treatment with the same device used for real neurostimulation
Intervention Type
Device
Intervention Name(s)
tDCS device from neuroConn
Intervention Description
weak electrical direct current stimulation
Primary Outcome Measure Information:
Title
Migraine days
Description
Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MR data
Description
Changes in functional and structural MR data before and after tDCS Treatment
Time Frame
6 months
Title
Clinical data
Description
Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable "migraine days
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Michels, PhD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34800989
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.
Results Reference
derived

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Neurostimulation in Chronic and Episodic Migraine

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