Migraine--Investigational Treatment of Migraine With Noninvasive Brain Stimulation. (tDCS- Migraine)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a painless and noninvasive procedure called
      Transcranial Direct Current Stimulation (tDCS) can be an effective therapy for the treatment
      of migraine and migraine-associated pain.

      Stimulation of the motor cortex with tDCS has already been shown to relieve pain in patients
      with other chronic pain syndromes, including traumatic spinal cord injury and fibromyalgia.
      Patients with migraine are usually extremely sensitive to pain. A treatment that targets the
      areas of the brain that are related to the experience of pain may also help decrease pain in
      patients with migraine. Pain control with this localized approach may help avoid the problems
      due to pain medications that affect all organs in the body.

      We hypothesize that 10 sessions of Transcranial Direct Current Stimulation (tDCS) applied
      over the area of the brain that controls pain and motor function will decrease pain and
      headache frequency in patients with migraine.
    

Detailed description: 
      We will rigorously test whether modulation of the motor cortex by tDCS is an effective
      treatment for patients with migraine through the following specific aims:

      A) The primary aim of this study is to determine whether transcranial direct current
      stimulation applied to the motor cortex in patients with migraine induces a significant
      decrease in the pain associated with migraine attacks as compared with sham tDCS. We will
      also measure changes in the number of migraine attacks, abortive drug intake (e.g. opioids,
      triptans), as well as overall improvement in the quality of life to assess the effects of
      this treatment.

      B) Determine whether the clinical effects of tDCS are long-lasting. We will therefore compare
      the amelioration of migraine-associated pain between active and sham tDCS after 1, 2 and 4
      months of treatment.

      C) Determine whether tDCS changes the threshold for pain detection as compared with sham
      tDCS. Patients with migraine have a lower threshold for pain as compared to healthy subjects
      and we hypothesize that this threshold as measured by Von Frey Hair Test and Quantitative
      Sensory Test will increase after stimulation with tDCS.

      D) Finally, we will examine whether 1 month of tDCS treatment is safe for use in migraine
      patients. Safety will be assessed through neuropsychological tests and adverse event
      reporting.
    

Intervention name(s): DC Stimulator (Transcranial Direct Current Stimulator)
Intervention type(s): Device
Intervention description(s): Subjects will receive a total of 10 sessions of either active tDCS or sham tDCS over a four-week period (administered every other day during weekdays over the course of one month). During each tDCS session, two electrodes are placed over selected areas of the brain. The anode is placed on the motor cortex contralateral to the side where migraines predominant; the cathode is placed near the supraorbital area, opposite the anode. A small battery powered device drives 2 mA of direct current through the two electrodes. The direct current will flow through the electrodes, penetrate the scalp, and create a flow of electrical current in the brain. The procedure will last 20 minutes. For sham tDCS, an alternate method of stimulation will be used.
Other intervention name(s): NeuroConn GmbH; http://www.eldith.de/products/stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine; headache; chronic; pain; brain; neurology; stimulation; noninvasive; transcranial; direct; current; tDCS; tms; rTMS; BIDMC