Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura

Migraine With Aura Clinical Trial

Official title:

Phase III Randomized Double-Blind Parallel Group Sham-Controlled Study Evaluating the Efficacy and Safety of Non-invasive Non-repetitive Transcranial Magnetic Stimulation (TMS) for the Acute Preemptive Treatment of the Aura Phase of Migraine Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449540
• Other study ID #: NL-2006-001
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2007
• Last updated: August 9, 2011
• Start date: August 2006
• Est. completion date: March 2008

Study information

• Verified date: July 2011
• Source: Neuralieve
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Assess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of migraine with aura

The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop or interrupt the spreading cortical brain activity that causes or contributes to the migraine headache. Two TMS treatments at an intensity of <1 Tesla for ~500 microseconds, approximately 30 seconds apart, may stop the aura and prevent the subsequent headache.

Description:

In the Lead-in Phase participants will use a Personal Digital Assistant (PDA) to keep an electronic diary of their migraine episodes. During a migraine episode, as well as the time in between headaches, the PDA prompts the participant to answer questions. Each evening, the participant will place the PDA into an electronic telephone cradle, and the information will be transmitted electronically from the PDA to the data management team to assess the frequency of migraine episodes and participant proficiency with the PDA. During this one month period, the participant must experience at least one migraine with aura episode to enter the Treatment Phase.

After one month, the participant will return to the clinic with their PDA and will enter the Treatment Phase to be randomized to either the TMS only group or the Sham stimulation only group. Participant will enter information into the PDA for three migraine auras treated or three months, which ever comes first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 - 65 years

• Will comply with requirements of the protocol

• Have a consistent history of migraine with visual aura of at least one year

•>30% of episodes have a visual aura preceding headaches

• Approximately 90% of the time have moderate or severe headaches following their aura

• Fulfills the International Classification of Headache Disorders, 2nd Edition(ICHD-II) criteria(for migraine headache with aura after administration of a clinical interview by study personnel

• Has a history of 1-8 migraine headache episodes with aura per month

• Can differentiate a migraine headache from other types of headaches

• Participant is post-menopausal, sterilized, not breastfeeding, her pregnancy test is negative

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Routinely experiences any other type of headache that would confound discrimination from migraine headache with aura

• Have migraine with prolonged aura > 60 minutes

• Have headaches due to other underlying pathology

• Have headaches related to head or neck trauma

• Overuse headache medications:

• Has an intracranial metallic or Transcranial Magnetic Stimulation (TMS) implant or other metallic implants

• Has cardiac pacemaker or any other implanted electronic device

• Has any known history of alcohol abuse, drug dependency, or significant psychiatric illness in the previous 12 months

• Having any medical condition, including but not limited to: clinically significant renal or hepatic disease; uncontrolled hypertension; clinically significant coronary vascular disease not stable for the past 6 months; personal or family history of seizures or taking medications for seizures or drugs that may lower seizure threshold, cerebral vascular ischemia; infarct; hemorrhage, or other central nervous system disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis); unstable metabolic disease, hypoglycemia or diabetes; malignancy within the past 5 years excluding cutaneous basal cell carcinoma; tuberculosis

• Has participated in any other investigational study within the previous 30 days.

• Cannot place the device within 1 cm of the scalp.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Intervention

Device:
• Active Transcranial Magnetic Stimulation (TMS) Device
Transcranial Magnetic Stimulation Device treatment
• Sham TMS Device
Simulated Sham treatment without TMS delivery

Locations

Country	Name	City	State
United States	The Innovative Clinical Research Center	Alexandria	Virginia
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Montefiore Headache Center	Bronx	New York
United States	Diamond Headache Clinic, LTD	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	Mile High Research Center	Denver	Colorado
United States	Westside Family Medical Center	Kalamazoo	Michigan
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	Kirchner Headache Clinic	Omaha	Nebraska
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	San Francisco Headache Clinic	San Francisco	California
United States	Swedish Headache Center	Seattle	Washington
United States	Clinvest, Inc.	Springfield	Missouri
United States	Mercy Health Research	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Neuralieve

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing no Pain at Two Hours Post-treatment	Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.	Two hours	No
Secondary	Percentage of Participants Who Have Symptoms of Nausea	Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.	two hours post treatment	No
Secondary	Percentage of Participants Who Have Symptoms Phonophobia	Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.	2 hours post treatment	No
Secondary	Percentage of Participants Who Have Photophobia	Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.	2 hours post treatment	No