MigraineNCT00521196
Migraine--Investigational Treatment of Migraine With Noninvasive Brain Stimulation. (tDCS- Migraine)
A study testing DC Stimulator (Transcranial Direct Current Stimulator) in people with Migraine, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- DC Stimulator (Transcranial Direct Current Stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to 13 Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center: Berenson-Allen Center for Noninvasive Brain Stimulation
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Migraine
- Being tested
- DC Stimulator (Transcranial Direct Current Stimulator)
- Keywords
- migraine, headache, chronic, pain, brain, neurology, stimulation, noninvasive, transcranial, direct, current, tDCS, tms, rTMS, BIDMC
- Medical subject headings
- Migraine Disorders, Headache, Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC Stimulator (Transcranial Direct Current Stimulator)Device
Also called NeuroConn GmbH, http://www.eldith.de/products/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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: DC Stimulator (Transcranial Direct Current Stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine-associated pain (maximum headache intensity)
Measured: 6 months
Migraine frequency (# of headache days per month)
Measured: 6 months
Daily average pain
Measured: 6 months
Secondary outcomes (4)
Thermal pain threshold
Measured: 1 month
Daily average anxiety
Measured: 6 months
Analgesic drug use
Measured: 6 months
Von Frey Hair
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startJul 2007
- Primary completion13 Jan 2012
- Study completion13 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Fregni, Beth Israel Deaconess Medical Center
- Investigators
- Felipe Fregni, MD, PhD, Principal investigator, Berenson-Allen Center for Noninvasive Brain Stimulation; Beth Israel Deaconess Medical CenterSoroush Zaghi, B.S., Study chair, Harvard Medical School; Beth Israel Deaconess Medical CenterAlexandre DaSilva, DDS, DMedSc, Study director, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521196
- Sponsor's protocol ID
- 2007P000145
- Status last verified
- Mar 2017
- First submitted
- 23 Aug 2007
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17611487Fregni 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.
PubMed 17239806Fregni 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.
PubMed 17133529Fregni 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.
PubMed 16564618Brighina 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.
PubMed 15546593
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Effect of Transcranial Direct Current Stimulation (tDCS) on Pain and Headache Frequency in Migraine.
- ClinicalTrials.gov ID
- NCT00521196
- Acronym / sponsor ID
- 2007P000145
- Conditions
- Migraine
- Keywords
- migraine, headache, chronic, pain, brain, neurology, stimulation, noninvasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- 13 Jan 2012 (actual)
- Study completion
- 13 Jan 2012 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: 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. |
| 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 | Device: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC Stimulator (Transcranial Direct Current Stimulator)Also: NeuroConn GmbH, http://www.eldith.de/products/stimulatorSubjects 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. | Device | Active tDCS- 1 month, tDCS- 1 month |
Primary outcome
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
4 secondary outcomes
Thermal pain threshold
Time frame: 1 month
Daily average anxiety
Time frame: 6 months
Analgesic drug use
Time frame: 6 months
Von Frey Hair
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Background: PubMed 17611487Fregni 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.
- Background: PubMed 17239806Fregni 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.
- Background: PubMed 17133529Fregni 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.
- Background: PubMed 16564618Fregni 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.
- Background: PubMed 15546593Brighina 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Fregni, MD, PhD principal investigator
Berenson-Allen Center for Noninvasive Brain Stimulation; Beth Israel Deaconess Medical Center
Soroush Zaghi, B.S. study chair
Harvard Medical School; Beth Israel Deaconess Medical Center
Alexandre DaSilva, DDS, DMedSc study director
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC Stimulator (Transcranial Direct Current Stimulator) in people with Migraine, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine-associated pain (maximum headache intensity) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521196, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.