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Completed

NCT Number: NCT00521196

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

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Key information

Conditions

Migraine Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Graft vs Host Disease Headache Headache Disorders Headache Disorders, Primary Immune System Diseases Lung Diseases Lung Diseases, Obstructive Migraine Disorders Nervous System Diseases Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: NeuroConn GmbH, http://www.eldith.de/products/stimulator

Primary outcomes

  1. Migraine-associated pain (maximum headache intensity)

    Time frame: 6 months

  2. Migraine frequency (# of headache days per month)

    Time frame: 6 months

  3. Daily average pain

    Time frame: 6 months

Secondary outcomes

  1. Thermal pain threshold

    Time frame: 1 month

  2. Daily average anxiety

    Time frame: 6 months

  3. Analgesic drug use

    Time frame: 6 months

  4. Von Frey Hair

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Phase 2 Study of the Effect of Transcranial Direct Current Stimulation (tDCS) on Pain and Headache Frequency in Migraine.

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2007
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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