Migraine Clinical Trial
Official title:
Phase 2 Study of the Effect of Transcranial Direct Current Stimulation (tDCS) on Pain and Headache Frequency in Migraine.
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.
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.
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