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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline- 1 month | No Intervention | Subjects will be asked to maintain a migraine diary in which they will record the onset of each migraine, migraine-associated symptoms, migraine-associated pain, daily average pain, and daily average anxiety. | |
| tDCS- 1 month | Experimental | There will be 10- twenty minute sessions of the tDCS intervention over a four week period. During each tDCS session, two electrodes are placed over selected areas of the brain. 2 mA of direct current will flow through the electrodes, penetrate the scalp, and create a flow of electrical current in the brain. The subject may feel a slight itching on the scalp. The procedure will last 20 minutes. For sham tDCS, an alternate method of stimulation will be used. During this phase, participants will continue to maintain their migraine diary. In addition, the pain threshold of patients will be measured at the first, fifth, and tenth sessions via Thermal Sensory Analysis and Von Frey Hair tests. |
|
| Follow Up- 4 months | No Intervention | During the follow up phase, subjects will meet with the study investigators a total of 5 times for follow up monitoring. Participants will continue to maintain their migraine diary during this time. | |
| Active tDCS- 1 month | Other | Participants randomized to sham tDCS (placebo) will be given the opportunity to receive the active intervention if the intervention is found to be safe and efficacious. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC Stimulator (Transcranial Direct Current Stimulator) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine-associated pain (maximum headache intensity) | 6 months | |
| Migraine frequency (# of headache days per month) | 6 months | |
| Daily average pain | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal pain threshold | 1 month | |
| Daily average anxiety | 6 months | |
| Analgesic drug use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD, PhD | Berenson-Allen Center for Noninvasive Brain Stimulation; Beth Israel Deaconess Medical Center | Principal Investigator |
| Soroush Zaghi, B.S. | Harvard Medical School; Beth Israel Deaconess Medical Center | Study Chair |
| Alexandre DaSilva, DDS, DMedSc | Mclean Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center: Berenson-Allen Center for Noninvasive Brain Stimulation | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17611487 | Background | Fregni F, Pascual-Leone A. Technology insight: noninvasive brain stimulation in neurology-perspectives on the therapeutic potential of rTMS and tDCS. Nat Clin Pract Neurol. 2007 Jul;3(7):383-93. doi: 10.1038/ncpneuro0530. | |
| 17239806 | Background | Fregni F, Freedman S, Pascual-Leone A. Recent advances in the treatment of chronic pain with non-invasive brain stimulation techniques. Lancet Neurol. 2007 Feb;6(2):188-91. doi: 10.1016/S1474-4422(07)70032-7. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D010146 | Pain |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 6 months |
| Von Frey Hair | 1 month |
| 17133529 | Background | Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195. |
| 16564618 | Background | Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27. |
| 15546593 | Background | Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008. |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |