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Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial (CATCHROMIG)

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ClinicalTrials.gov Identifier: NCT02122237
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, University of Liege

Tracking Information
First Submitted Date  ICMJE November 4, 2013
First Posted Date  ICMJE April 24, 2014
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
Migraine frequency [ Time Frame: 6 months ]
The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02122237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
  • Migraine intensity [ Time Frame: 6 months ]
    The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.
  • Acute medication intake [ Time Frame: 6 months ]
    The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.
  • Attack duration [ Time Frame: 6 months ]
    The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.
  • Scores at psychological scales [ Time Frame: 6 months ]
    The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end.
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 Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Official Title  ICMJE Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Brief Summary Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.
Detailed Description

During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a "never ending migraine attack" accompanied by cortical hypersensitivity.

In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Migraine
Intervention  ICMJE Device: Cefaly tDCS
Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
Study Arms  ICMJE Experimental: Cathodal Cefaly tDCS
Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, everyday for 2 months, in 14 patients. The anode is placed over the left DLPFC.
Intervention: Device: Cefaly tDCS
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2014)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria:

  • others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02122237
Other Study ID Numbers  ICMJE CB-1289
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean Schoenen, University of Liege
Study Sponsor  ICMJE University of Liege
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Delphine Magis, MD,PhD University of Liège
Study Director: Jean Schoenen, MD,PhD University of Liège
PRS Account University of Liege
Verification Date May 2015

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