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Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache

NCT ID: NCT01752439

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.

Detailed Description

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Conditions

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Chronic Migraine Medication Overuse Headache

Keywords

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Chronic Migraine Medication Overuse Headache Refractory transcranial direct current stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anodal transcranial direct current stimulation

Anodal transcranial direct current stimulation

Group Type EXPERIMENTAL

Anodal transcranial direct current stimulation

Intervention Type DEVICE

Sham transcranial direct current stimulation

Sham transcranial direct current stimulation

Group Type SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type DEVICE

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anodal transcranial direct current stimulation

Intervention Type DEVICE

Sham transcranial direct current stimulation

Intervention Type DEVICE

Other Intervention Names

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Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy

Eligibility Criteria

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Inclusion Criteria

* Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)

Exclusion Criteria

* Other primary or secondary headaches.
* Any serious systemic or neurological disease or psychiatric disorder.
* Pregnancy or breastfeeding
* Previous or current use of other or similar devices for pain control
* Heart conduction and rhythm disorders
* Cranial surgery
* Other pain conditions, accordingly with current guidelines
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Armando Perrotta, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Dr Armando Perrotta, MD, PhD

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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tDCSCMMOH1

Identifier Type: -

Identifier Source: org_study_id