Clinical trial NCT00521196: Migraine--Investigational Treatment of Migraine With Noninvasive Brain Stimulation. (tDCS- Migraine)
Official title: Phase 2 Study of the Effect of Transcranial Direct Current Stimulation (tDCS) on Pain and Headache Frequency in Migraine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
headache
chronic
pain
brain
neurology
stimulation
noninvasive
transcranial
direct
current
tDCS
tms
rTMS
BIDMC
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2007-08-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects must be between 18 and 65 years of age.
* The diagnosis must meet the 2004 IHS criteria for migraine without aura, migraine with aura, or chronic migraine.
* The duration of the disease must be of at least one year.
* Subjects must have maintained their routine preventative medication consistently for at least two months (if applicable) prior to study initiation.

Exclusion Criteria:

* Patients with major depression with suicidal risk, as clinically defined.
* Patients with other known neuropsychiatric disorders.
* Patients with other chronic pain disorders
* History of substance abuse or dependence within the last six months
* Known brain metastasis
* History of neurological disorders (such as stroke)
* History of brain surgery
* Prior experience with tDCS
* Abnormal neurological examination, other than those pertaining to the signs of the condition studied in this protocol.
* Contraindication to tDCS: metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding

Primary outcomes:
measure: Migraine-associated pain (maximum headache intensity)
timeFrame: 6 months
measure: Migraine frequency (# of headache days per month)
timeFrame: 6 months
measure: Daily average pain
timeFrame: 6 months
Secondary outcomes:
measure: Thermal pain threshold
timeFrame: 1 month
measure: Daily average anxiety
timeFrame: 6 months
measure: Analgesic drug use
timeFrame: 6 months
measure: Von Frey Hair
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center: Berenson-Allen Center for Noninvasive Brain Stimulation
state: Massachusetts
Study officials:
affiliation: Berenson-Allen Center for Noninvasive Brain Stimulation; Beth Israel Deaconess Medical Center
name: Felipe Fregni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School; Beth Israel Deaconess Medical Center
name: Soroush Zaghi, B.S.
role: STUDY_CHAIR
affiliation: Mclean Hospital
name: Alexandre DaSilva, DDS, DMedSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.