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

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Device: DC Stimulator (Transcranial Direct Current Stimulator)

• Registration Number: NCT00521196
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-23
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Primary Completion: 2012-01-13
• Study Completion: 2012-01-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS- 1 month	DC Stimulator (Transcranial Direct Current Stimulator)	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.
tDCS- 1 month	DC Stimulator (Transcranial Direct Current Stimulator)	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.

Primary Outcome Measures

Name	Time	Method
Daily average pain	6 months
Migraine-associated pain (maximum headache intensity)	6 months
Migraine frequency (# of headache days per month)	6 months

Secondary Outcome Measures

Name	Time	Method
Thermal pain threshold	1 month
Daily average anxiety	6 months
Analgesic drug use	6 months
Von Frey Hair	1 month

Trial Locations

Locations (1)

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