Phase 2 Study of the Effect of Transcranial Direct Current Stimulation (tDCS) on Pain and Headache Frequency in Migraine.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Migraine-associated pain (maximum headache intensity)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: DC Stimulator (Transcranial Direct Current Stimulator) (Device)
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.
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.
Intervention: DC Stimulator (Transcranial Direct Current Stimulator) (Device)
Outcomes
Primary Outcomes
Migraine-associated pain (maximum headache intensity)
Time Frame: 6 months
Migraine frequency (# of headache days per month)
Time Frame: 6 months
Daily average pain
Time Frame: 6 months
Secondary Outcomes
- Thermal pain threshold(1 month)
- Daily average anxiety(6 months)
- Analgesic drug use(6 months)
- Von Frey Hair(1 month)
Investigators
Felipe Fregni
Associate Professor of Physical Medicine and Rehabilitation
Beth Israel Deaconess Medical Center