MigraineNCT01265797
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
A study testing Cranial Electrostimulator in people with Migraine, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain relief in migraine patients. However, despite the number of CES studies done, many have been open label, single blinded, or have utilized a small group of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Cranial Electrostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 satisfying the IHS (International Headache Society) criteria for migraine
- Subjects have not achieved satisfactory pain control on their current medication
- Ability to maintain a daily headache diary
- Stable medication use related to migraine for at least 4 weeks prior to enrollment in the study
Who cannot join
- Previous exposure to or experience with cranial electrotherapy stimulation (CES)
- Contraindications to Fisher Wallace stimulator, such as cardiac pacemakers or implantable defibrillators, known or suspected heart disease, or pregnancy
- Seizure disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain relief in migraine patients. However, despite the number of CES studies done, many have been open label, single blinded, or have utilized a small group of patients.
Read the detailed description
This study will evaluate the efficacy of the Fisher Wallace Cranial Stimulator in persons with chronic migraine who have not achieved satisfactory pain control on their current medications.
- Conditions
- Migraine
- Being tested
- Cranial Electrostimulator, Sham Device
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial ElectrostimulatorDevice
Also called Fisher Wallace Cranial Electrostimulator
participant wears active cranial electrostimulation device for 20 minutes daily for 28 days
Sham DeviceDevice
participant wears sham device for 20 minutes daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Cranial Electrostimulator | Active comparator | wears active cranial electrostimulation device for 20 minutes daily for 28 days Receives: Device: Cranial Electrostimulator |
| Sham device | Sham comparator | wears sham device for 20 minutes daily for 28 days Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Headache Days
Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).
Measured: 28 day period during run-in month and blinded month
Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)
Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.
Measured: 14 days recall; measured at end of run-in month and blinded month
Secondary outcomes (10)
Headache Days
Mean change in headache days between 28 day run-in month and 28 day open label month, i.e. run-in month mean minus open label month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).
Measured: 28 day period in run-in month and open label month
Depression Score (Patient Health Questionnaire-9)
Mean difference of PHQ-9 score between the run-in month and open label month, i.e. PHQ-9 score from run-in month minus open label month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.
Measured: 14 day recall, recorded at the end of run-in and open label months
Headache Impact Test-6
Mean difference in HIT-6 score between run-in month and blinded month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.
Measured: after run-in month, after blinded month
Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)
Mean difference in HIT-6 score between run-in month and open label month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.
Measured: 28 day period in run-in month and open label month
Generalized Anxiety Disorder Score (GAD 7)
Mean difference in GAD 7 score between run-in month and blinded month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety
Measured: 14 days recall; measured at end of run-in month and blinded month
Generalized Anxiety Disorder Score (GAD 7)
Mean difference in GAD 7 score between run-in month and open label month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety
Measured: 14 day recall, recorded at the end of run-in and open label months
Somatic Symptom Severity (Patient Health Questionnaire 15)
Mean difference in PHQ 15 score between run-in month and blinded month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms
Measured: 28 days recall; measured at end of run-in month and blinded month
Somatic Symptom Score (Patient Health Questionnaire-15)
Mean difference in PHQ 15 score between run-in month and open label month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms.
Measured: 28 day period in run-in month and open label month
Epworth Sleepiness Scale Score
Mean difference of Epworth Sleepiness Scale score between run-in month and blinded month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in "recent times". The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep.
Measured: recorded at the end of run-in month and blinded month
Epworth Sleepiness Scale Score
Mean difference of Epworth Sleepiness Scale score between run-in month and open label month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in "recent times". The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep.
Measured: Score recorded at the end of run-in and open label month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gretchen Tietjen, MD, University of Toledo Health Science Campus
- Investigators
- Gretchen Tietjen, MD, Principal investigator, University of Toledo, HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265797
- Sponsor's protocol ID
- UTHSC-13
- Status last verified
- Feb 2015
- First submitted
- 15 Dec 2010
- Last updated
- 10 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
- ClinicalTrials.gov ID
- NCT01265797
- Acronym / sponsor ID
- UTHSC-13
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain relief in migraine patients. However, despite the number of CES studies done, many have been open label, single blinded, or have utilized a small group of patients.
Detailed description
This study will evaluate the efficacy of the Fisher Wallace Cranial Stimulator in persons with chronic migraine who have not achieved satisfactory pain control on their current medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial Electrostimulator | Active comparator | Device: Cranial Electrostimulatorwears active cranial electrostimulation device for 20 minutes daily for 28 days |
| Sham device | Sham comparator | Device: Sham Devicewears sham device for 20 minutes daily for 28 days |
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 satisfying the IHS (International Headache Society) criteria for migraine
- Subjects have not achieved satisfactory pain control on their current medication
- Ability to maintain a daily headache diary
- Stable medication use related to migraine for at least 4 weeks prior to enrollment in the study
Key exclusion criteria (3 listed)
- Previous exposure to or experience with cranial electrotherapy stimulation (CES)
- Contraindications to Fisher Wallace stimulator, such as cardiac pacemakers or implantable defibrillators, known or suspected heart disease, or pregnancy
- Seizure disorders
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 |
|---|---|---|
| Cranial ElectrostimulatorAlso: Fisher Wallace Cranial Electrostimulatorparticipant wears active cranial electrostimulation device for 20 minutes daily for 28 days | Device | Cranial Electrostimulator |
| Sham Deviceparticipant wears sham device for 20 minutes daily for 28 days | Device | Sham device |
Primary outcome
Mean Headache Days
Time frame: 28 day period during run-in month and blinded month
Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).
Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)
Time frame: 14 days recall; measured at end of run-in month and blinded month
Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.
10 secondary outcomes
Headache Days
Time frame: 28 day period in run-in month and open label month
Depression Score (Patient Health Questionnaire-9)
Time frame: 14 day recall, recorded at the end of run-in and open label months
Headache Impact Test-6
Time frame: after run-in month, after blinded month
Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)
Time frame: 28 day period in run-in month and open label month
Generalized Anxiety Disorder Score (GAD 7)
Time frame: 14 days recall; measured at end of run-in month and blinded month
Generalized Anxiety Disorder Score (GAD 7)
Time frame: 14 day recall, recorded at the end of run-in and open label months
Somatic Symptom Severity (Patient Health Questionnaire 15)
Time frame: 28 days recall; measured at end of run-in month and blinded month
Somatic Symptom Score (Patient Health Questionnaire-15)
Time frame: 28 day period in run-in month and open label month
Epworth Sleepiness Scale Score
Time frame: recorded at the end of run-in month and blinded month
Epworth Sleepiness Scale Score
Time frame: Score recorded at the end of run-in and open label month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gretchen Tietjen, MD principal investigator
University of Toledo, HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Electrostimulator in people with Migraine, run by University of Toledo Health Science Campus 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 3 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 10 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Headache Days (time frame: 28 day period during run-in month and blinded month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2015.