NCT00521196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2012

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

4.5 years

First QC Date

August 23, 2007

Last Update Submit

March 17, 2017

Conditions

Migraine

Keywords

migraineheadachechronicpainbrainneurologystimulationnoninvasivetranscranialdirectcurrenttDCStmsrTMSBIDMC

Outcome Measures

Primary Outcomes (3)

  • Migraine-associated pain (maximum headache intensity)

    6 months

  • Migraine frequency (# of headache days per month)

    6 months

  • Daily average pain

    6 months

Secondary Outcomes (4)

  • Thermal pain threshold

    1 month

  • Daily average anxiety

    6 months

  • Analgesic drug use

    6 months

  • Von Frey Hair

    1 month

Study Arms (4)

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)

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.

Device: DC Stimulator (Transcranial Direct Current Stimulator)

Interventions

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.

Also known as: NeuroConn GmbH, http://www.eldith.de/products/stimulator
Active tDCS- 1 monthtDCS- 1 month

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center: Berenson-Allen Center for Noninvasive Brain Stimulation

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

  • 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.

    PMID: 17611487BACKGROUND

  • 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.

    PMID: 17239806BACKGROUND

  • 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.

    PMID: 17133529BACKGROUND

  • 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.

    PMID: 16564618BACKGROUND

  • 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.

    PMID: 15546593BACKGROUND

Related Links

MeSH Terms

Conditions

Migraine DisordersHeadacheBronchiolitis Obliterans SyndromePain

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 27, 2007

Study Start

July 1, 2007

Primary Completion

January 13, 2012

Study Completion

January 13, 2012

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

US(1)