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Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine (Medis)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02120326
First received: April 15, 2014
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.

Condition Intervention
Chronic Migraine as Defined by Criteria of International Headache Society (IHS) Device: Transcranial direct current stimulation of the motor cortex Device: simulation of Transcranial direct current stimulation of the motor cortex

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Comparison of the evolution of seizure frequency between the two groups [ Time Frame: Evolution of seizure frequency since base line to 3 months after the end of tDCS ]

Secondary Outcome Measures:
  • Comparison of the evolution of seizure severity between the two groups [ Time Frame: Evolution of seizure severity since base line to 3 months after the end of tDCS ]
    Headache Impact Test 6 (HIT-6) questionnaire

  • Comparison of the evolution of crisis treatment use between the two groups [ Time Frame: Evolution of crisis treatment use since base line until 3 months after the end of tDCS ]
    Frequency of taking crisis treatment. After each crisis, taking crisis treatment will be noted by the patient on his migraine record book.

  • Comparison of the evolution of the disease impact between the two groups [ Time Frame: Evolution of the disease impact since base line to 3 months after the end of tDCS ]
    Migraine Disability Assessment Scale (MIDAS) scale

  • Comparison of the evolution of the patient satisfaction between the two groups [ Time Frame: Evolution of the patient satisfaction since base line to 3 months after the end of tDCS ]
    Clinical Global Impression (CGI) scale

  • Comparison of the evolution of the quality of life between the two groups [ Time Frame: Evolution of the quality of life since base line until 3 months after the end of tDCS ]
    Short Form 12 (SF-12) quality of life questionnaire

  • Comparison of the evolution of anxiety and depression levels between the two groups [ Time Frame: Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS ]
    Hospital Anxiety and Depression scale (HAD) questionnaire


Estimated Enrollment: 60
Actual Study Start Date: May 5, 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active tDCS Device: Transcranial direct current stimulation of the motor cortex

The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.

Stimulation parameters:

  • 2 mA intensity
  • Continuous stimulation for 20 min with rise times and fall times of 10 seconds each
Placebo Comparator: simulated tDCS Device: simulation of Transcranial direct current stimulation of the motor cortex

The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.

Stimulation parameters:

  • The intensity of the stimulation current is 2 mA
  • The current is applied during the first 30 seconds with rise times and fall times of 10 seconds each. Then the session will be continued without actual stimulation.

Detailed Description:

Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed for 3 months. Throughout their participation in the study, patients will complete their migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS).

Patients will have 5 evaluation examinations:

  • The first, one before tDCS,
  • The second, 1 month after the beginning of tDCS
  • The third, immediately after the end of tDCS
  • The fourth, 1 month after the end of tDCS
  • And the last one, 3 months after the end of tDCS.

The physician responsible for conducting tDCS sessions will make the randomization via a website.

The physician in charge of the evaluation examinations will don't know the allocated treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic migraine for more than 1 year
  • Stable treatment since 1 month
  • Frequency of migraine crisis is above 8 per month during last month
  • chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
  • Patient agreeing not to try other migraine prophylactic treatment, throughout the study
  • Patient's written consent

Exclusion Criteria:

  • History of drug addiction, epilepsy, or severe head trauma with bone break
  • History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
  • Presence of intracranial ferromagnetic material or an implanted stimulator
  • Introduction of a new treatment for less than a month
  • Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
  • Person not understanding the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120326

Contacts
Contact: Hasan HODAJ, MD +33 4 76 76 52 13 HHodaj@chu-grenoble.fr

Locations
France
Grenoble University Hospital Recruiting
Grenoble, Isere, France, 38043
Contact: HODAJ Hasan, MD    33 4 76 76 52 13      
Sub-Investigator: ALIBEU Jean-Pierre, MD         
Sub-Investigator: NOELLE Bénédicte, MD         
Hospital of Voiron Recruiting
Voiron, Isere, France, 38500
Contact: MICK Gerard, MD, PHD    +33 4 76 67 15 15      
Principal Investigator: MICK Gérard, MD, PHD         
Sub-Investigator: RAMPINNEAU Jean-Pierre, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: HODAJ Hasan, MD University Hospital, Grenoble
  More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02120326     History of Changes
Other Study ID Numbers: DCIC13/48
Study First Received: April 15, 2014
Last Updated: May 2, 2017

Keywords provided by University Hospital, Grenoble:
Chronic migraine, tDCS, Transcranial direct current stimulation

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 19, 2017