Migraine--Investigational Treatment of Migraine With Noninvasive Brain Stimulation. (tDCS- Migraine) - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00521196

Purpose

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.

Condition	Intervention	Phase
Migraine	Device: DC Stimulator (Transcranial Direct Current Stimulator)	Phase II

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of the Effect of Transcranial Direct Current Stimulation (tDCS) on Pain and Headache Frequency in Migraine.

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Migraine-associated pain (maximum headache intensity) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Migraine frequency (# of headache days per month) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Daily average pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Thermal pain threshold [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Daily average anxiety [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Analgesic drug use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Von Frey Hair [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Device: DC Stimulator (Transcranial Direct Current Stimulator) 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.
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 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.	Device: DC Stimulator (Transcranial Direct Current Stimulator) 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.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521196

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center: Berenson-Allen Center for Noninvasive Brain Stimulation
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:	Felipe Fregni, MD, PhD	Berenson-Allen Center for Noninvasive Brain Stimulation; Beth Israel Deaconess Medical Center
Study Chair:	Soroush Zaghi, B.S.	Harvard Medical School; Beth Israel Deaconess Medical Center
Study Director:	Alexandre DaSilva, DDS, DMedSc	Mclean Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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. Epub 2006 Mar 27.

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.

Responsible Party:	BIDMC ( Felipe Fregni )
Study ID Numbers:	2007P-000145
Study First Received:	August 23, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00521196
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

migraine
headache
chronic
pain
brain
neurology
stimulation
noninvasive

transcranial
direct
current
tDCS
tms
rTMS
BIDMC

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary

Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009