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

March 17, 2017 updated by: Felipe Fregni, Beth Israel Deaconess Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Baseline- 1 month
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.
Experimental: tDCS- 1 month

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.
Other Names:
  • NeuroConn GmbH
  • http://www.eldith.de/products/stimulator
No Intervention: Follow Up- 4 months
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.
Other: 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.
Other Names:
  • NeuroConn GmbH
  • http://www.eldith.de/products/stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Migraine-associated pain (maximum headache intensity)
Time Frame: 6 months
6 months
Migraine frequency (# of headache days per month)
Time Frame: 6 months
6 months
Daily average pain
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Thermal pain threshold
Time Frame: 1 month
1 month
Daily average anxiety
Time Frame: 6 months
6 months
Analgesic drug use
Time Frame: 6 months
6 months
Von Frey Hair
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2007

Primary Completion (Actual)

January 13, 2012

Study Completion (Actual)

January 13, 2012

Study Registration Dates

First Submitted

August 23, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P000145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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