Post-Traumatic HeadacheNCT04906603
Theta Burst Stimulation for Headaches After Traumatic Brain Injury
A study testing Theta Burst Stimulation in people with Post-Traumatic Headache and Transcranial Magnetic Stimulation, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if theta burst stimulation (TBS) can reduce chronic headaches caused by a traumatic brain injury (TBI). TBS is a safe, drug-free brain stimulation technique that uses magnets to create electricity and stimulate nerve cells in the brain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Traumatic Headache, Transcranial Magnetic Stimulation, Brain Injuries, Traumatic
- What is being tested?
- Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to Sep 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans receiving services through the MVAHCS
- History of mild TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
- Loss of consciousness between 0-30 minutes
- Post-traumatic amnesia between 0-24 hours
- Alteration of consciousness/mental state up to 24 hours
- Glasgow Coma Score between 13-15 (best available score within first 24 hours)
Show all 14Show fewer
- Post-traumatic headaches defined by International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines with the following criteria present:
- Headaches developing within seven days following trauma or injury to the head and/or neck
- Headaches persisting beyond three months
- Chronic daily headaches defined by clinical standards with the following criterion present:
- o 15 or more headache days per month
- Men and women 18-75 years of age
- Possess a smartphone and agree to download and use the EMA application on their personal device
- Capable and willing to provide voluntary informed consent
Who cannot join
- History of moderate or severe TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
- Loss of consciousness greater than 30 minutes
- Post-traumatic amnesia greater than 24 hours
- Worst Glasgow Coma Scale less than 13 within the first 24 hours unless invalidated upon review (e.g., attributable to intoxication, sedation, systemic shock)
- Abnormal structural imaging
- Current (within six months of enrollment) psychosis and mania
Show all 19Show fewer
- Current (within one month of enrollment) substance dependence with the exclusion of opioids
- Personal history of epilepsy or seizure disorder
- o Does not include seizures therapeutically-induced by ECT or identified as a single seizure event (based on the principal investigator's judgement)
- Metal particles in the eye or head (exclusive of the mouth) (e.g., shrapnel, fragments from welding or metalwork, etc.)
- Implanted medical device above the clavicle (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes, etc.)
- Significant neurological disorder or insult that would impact risk (based on the principal investigator's judgement and research literature)
- Current use of medications with significant potential for lowering seizure threshold
- Current benzodiazepine usage at a dose higher than 3mg of lorazepam or equivalent
- Electroconvulsive therapy (ECT) or cortical energy exposure within one month of enrollment (including participation in any other neuromodulation treatments or studies)
- Current (within one month of enrollment) participation in another interventional study that would impact the results of this research
- Inadequate communication (e.g., language barrier)
- Women who are pregnant, trying to become pregnant, or breastfeeding
- Women of childbearing age/potential who are not using a medically-accepted form of contraception when sexually active
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
Katrina Friedrich, 612-467-1811, Katrina.Friedrich@va.gov
About this study
The purpose of this study is to evaluate if theta burst stimulation (TBS) can reduce chronic headaches caused by a traumatic brain injury (TBI). TBS is a safe, drug-free brain stimulation technique that uses magnets to create electricity and stimulate nerve cells in the brain. After repeated TBS sessions, the increased stimulation of nerve cells can alter the way the brain communicates with itself (by creating new neural pathways) which, in turn, can reduce pain symptoms. Participants in this study will complete a baseline assessment followed by four weeks of daily home headache assessment. Participants will then receive four weeks of TBS administered three times per day and three days per week. After TBS is completed, participants will complete an additional four weeks of daily home headache assessment and return for a one-month follow-up assessment. Participation is expected to last three months.
Read the detailed description
The primary objective of this study is to investigate the safety and efficacy of theta burst stimulation (TBS) for the management of post-traumatic headaches to improve outcomes and quality of life for individuals who have suffered a traumatic brain injury (TBI). To improve tolerability and logistical burden, we have developed a novel design whereby participants will receive three doses of TBS on alternate days of the week. This design will allow us to assess efficacy while leveraging an accelerated treatment course (nine stimulation sessions per week). We have three specific aims:
Specific Aim 1. To determine the efficacy and safety of TBS for the treatment of post-traumatic headache among individuals who have sustained a mild TBI. Hypothesis 1a: TBS will be safe, well-tolerated, and reduce the number of headache days. Hypothesis 1b: TBS will improve function and quality of life outcomes.
Specific Aim 2: To determine the efficacy and safety of an accelerated time-course of TBS for the management of post-traumatic headache. Hypothesis 2a: The accelerated-time course will be safe, well-tolerated, and improve quality of life outcomes. Hypothesis 2b: The accelerated time-course will produce greater and faster improvement in headache symptoms than that reported in the literature for standard repetitive transcranial magnetic stimulation (rTMS) protocols.
Specific Aim 3: To examine the durability of treatment response to accelerated TBS during a one-month observational period. Hypothesis 3: Accelerated TBS will result in enduring treatment response of post-traumatic headache symptoms over the follow-up period.
This study will be an open-label pilot study and will enroll 20. Participants will complete four weeks of pre-intervention headache assessment via Ecological Momentary Assessment (EMA). Participants will then receive TBS intervention three times a week for four weeks. TBS will be administered in 10-minute sessions, three times per day with 20 minutes between sessions. TBS intervention will be completed using the Magstim Horizon Performance Transcranial Magnetic Stimulation (Magstim Company, Ltd.) device or the MagVenture MagPro X100 with MagOption Transcranial Magnetic Stimulation device (MagVenture, Inc.). Both devices are FDA-cleared to provide TBS for the treatment of Major Depressive Disorder and will be used off-label for this study. After TBS intervention, participants will complete an additional four weeks of EMA headache assessment and return for a one-month follow-up assessment. Participants will be assessed with multiple instruments and at multiple timepoints including interviews, questionnaires, and cognitive functioning assessments.
- Conditions
- Post-Traumatic Headache, Transcranial Magnetic Stimulation, Brain Injuries, Traumatic, Quality of Life
- Being tested
- Theta Burst Stimulation
- Medical subject headings
- Post-Traumatic Headache, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta Burst StimulationDevice
TBS will be administered three times per day and three days per week for four weeks (totaling 12 TBS intervention visits and 36 TBS intervention sessions). Each TBS intervention session will last approximately 10 minutes (stimulation parameters = 50 Hz, 3 pulses, 10 bursts, 10 second cycle time, 60 cycles, 1800 total pulses).
| Study group | Role | What they receive |
|---|---|---|
| TBS Headache | Experimental | Not described Receives: Device: Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecological Momentary Assessment (EMA) for Headache Frequency, Intensity, and Impairment
EMA will be used for repeated real-time sampling of headaches symptoms prior to intervention, during intervention, and after intervention. Participants will access the EMA application (app) on their personal smartphones.
Measured: Participants will take the daily headache assessment every day for 2 weeks pre-intervention, every day for 4 weeks during intervention, and every day for 4 weeks post-intervention to track their change in headache frequency, intensity, and impairment.
World Health Organization Quality of Life Scale (WHOQOL-BREF)
The WHOQOL-BREF is a 26-item self-report assessment of quality of life and will be used to assess changes in QOL over the course of the study. Items are rated on a scale from 1 (very poor) to 5 (very good).
Measured: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Migraine Disability Assessment (MIDAS)
The MIDAS is a 5-item self-report assessment of headache disability and will be used to assess change in headache impairment over the course of the study. Participants are to respond with the number of days they have experienced various types of headache disability. The last question asks them to rate on a scale from 0 (no pain at all) to 10 (pain as bad as it can be).
Measured: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Patient-Reported Outcomes Measurement Information System - Pain Interference - Short Form 6b (PROMIS-SF6b)
The PROMIS-SF6b is a 6-item self-report assessment of pain interference and will be used to assess change in universal (non-headache specific) pain over the course of the study. Items are rated on a 5 point scale from "Not at all" to "Very Much".
Measured: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Secondary outcomes (8)
Barratt Impulsiveness Scale - Version 11 (BIS-11)
The BIS-11 is a 30-item self-report measure of impulsivity and will be used to assess change in impulsive behavior over the course of the study. Items are rated on a 4 point scale from "Rarely or never" to "Almost always or always".
Measured: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Beck Anxiety Inventory (BAI)
The BAI is a 21-item self report assessment of anxiety severity and will be used to assess change in mood over the course of the study. Items are rated on a 4 point scale from "Not at all" to "Severely---it bothered me a lot."
Measured: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
The QIDS-SR is a 16-item self-report assessment of depression severity and will be used to assess change in mood over the course of the study. Each item has 4 choices that specifically tie in to the question. For example:
Question 1. Falling asleep
- I never take longer than 30 minutes to fall asleep
- I take at least 30 minutes to fall asleep, less than half the time.
- I take at least 30 minutes to fall asleep, more than half the time.
- I take more than 60 minutes to fall asleep, more than half the time.
Measured: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
PTSD Checklist for DSM-V (PCL-5)
The PCL-5 is a 20-item self-report measure of post-traumatic stress disorder (PTSD) symptoms and severity and will be used to assess change in mood over the course of the study. Items are rated on a 5 point scale from "Not at all" to "Extremely".
Measured: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Dot Counting (Cognitive Task)
The Dot Counting Task is a computerized measure of verbal working memory.
Measured: The dot counting task will be administered at every stimulation visit during the 4 weeks of intervention (total of 12 times).
N-Back (Cognitive Task)
The N-Back Task is a continuous performance test that is used to measure working memory and processing speed.
Measured: The N-Back task will be administered at every stimulation visit during the 4 weeks of intervention (a total of 12 times).
Risk Task (Cognitive Task)
The Risk Task is a computerized behavioral measure of the propensity for risk taking within a decision making task.
Measured: The risk task will be administered at every stimulation visit during the 4 weeks of intervention ( a total of 12 times).
Caffeine and Nicotine Use Questionnaire
The Caffeine and Nicotine Use Questionnaire is a proprietary measure used to record typical patterns of caffeine and nicotine use at study baseline. Daily caffeine and nicotine use will then be tracked over the course of the study using EMA.
Measured: Baseline and daily for 10 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Nov 2019
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Minnesota Office of Higher Education, The Defense and Veterans Brain Injury Center
- Responsible party
- Principal investigator, Cristina Sophia Albott, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906603
- Sponsor's protocol ID
- VAM-19-00458
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Final data sets may be made available upon written request and subject to sponsor approval.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Stimulation for Headaches After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04906603
- Acronym / sponsor ID
- VAM-19-00458
- Conditions
- Post-Traumatic Headache, Transcranial Magnetic Stimulation, Brain Injuries, Traumatic, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Minnesota Office of Higher Education, The Defense and Veterans Brain Injury Center
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 28 May 2021 (actual)
- 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 evaluate if theta burst stimulation (TBS) can reduce chronic headaches caused by a traumatic brain injury (TBI). TBS is a safe, drug-free brain stimulation technique that uses magnets to create electricity and stimulate nerve cells in the brain. After repeated TBS sessions, the increased stimulation of nerve cells can alter the way the brain communicates with itself (by creating new neural pathways) which, in turn, can reduce pain symptoms. Participants in this study will complete a baseline assessment followed by four weeks of daily home headache assessment. Participants will then receive four weeks of TBS administered three times per day and three days per week. After TBS is completed, participants will complete an additional four weeks of daily home headache assessment and return for a one-month follow-up assessment. Participation is expected to last three months.
Detailed description
The primary objective of this study is to investigate the safety and efficacy of theta burst stimulation (TBS) for the management of post-traumatic headaches to improve outcomes and quality of life for individuals who have suffered a traumatic brain injury (TBI). To improve tolerability and logistical burden, we have developed a novel design whereby participants will receive three doses of TBS on alternate days of the week. This design will allow us to assess efficacy while leveraging an accelerated treatment course (nine stimulation sessions per week). We have three specific aims:
Specific Aim 1. To determine the efficacy and safety of TBS for the treatment of post-traumatic headache among individuals who have sustained a mild TBI. Hypothesis 1a: TBS will be safe, well-tolerated, and reduce the number of headache days. Hypothesis 1b: TBS will improve function and quality of life outcomes.
Specific Aim 2: To determine the efficacy and safety of an accelerated time-course of TBS for the management of post-traumatic headache. Hypothesis 2a: The accelerated-time course will be safe, well-tolerated, and improve quality of life outcomes. Hypothesis 2b: The accelerated time-course will produce greater and faster improvement in headache symptoms than that reported in the literature for standard repetitive transcranial magnetic stimulation (rTMS) protocols.
Specific Aim 3: To examine the durability of treatment response to accelerated TBS during a one-month observational period. Hypothesis 3: Accelerated TBS will result in enduring treatment response of post-traumatic headache symptoms over the follow-up period.
This study will be an open-label pilot study and will enroll 20. Participants will complete four weeks of pre-intervention headache assessment via Ecological Momentary Assessment (EMA). Participants will then receive TBS intervention three times a week for four weeks. TBS will be administered in 10-minute sessions, three times per day with 20 minutes between sessions. TBS intervention will be completed using the Magstim Horizon Performance Transcranial Magnetic Stimulation (Magstim Company, Ltd.) device or the MagVenture MagPro X100 with MagOption Transcranial Magnetic Stimulation device (MagVenture, Inc.). Both devices are FDA-cleared to provide TBS for the treatment of Major Depressive Disorder and will be used off-label for this study. After TBS intervention, participants will complete an additional four weeks of EMA headache assessment and return for a one-month follow-up assessment. Participants will be assessed with multiple instruments and at multiple timepoints including interviews, questionnaires, and cognitive functioning assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label pilot study
| Arm | Type | Receives |
|---|---|---|
| TBS Headache | Experimental | Device: Theta Burst Stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Veterans receiving services through the MVAHCS
- History of mild TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
- Post-traumatic headaches defined by International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines with the following criteria present:
- Chronic daily headaches defined by clinical standards with the following criterion present:
- o 15 or more headache days per month
Key exclusion criteria (19 listed)
- History of moderate or severe TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
- Current (within six months of enrollment) psychosis and mania
- Current (within one month of enrollment) substance dependence with the exclusion of opioids
- Personal history of epilepsy or seizure disorder
- o Does not include seizures therapeutically-induced by ECT or identified as a single seizure event (based on the principal investigator's judgement)
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 |
|---|---|---|
| Theta Burst StimulationTBS will be administered three times per day and three days per week for four weeks (totaling 12 TBS intervention visits and 36 TBS intervention sessions). Each TBS intervention session will last approximately 10 minutes (stimulation parameters = 50 Hz, 3 pulses, 10 bursts, 10 second cycle time, 60 cycles, 1800 total pulses). | Device | TBS Headache |
Primary outcome
Ecological Momentary Assessment (EMA) for Headache Frequency, Intensity, and Impairment
Time frame: Participants will take the daily headache assessment every day for 2 weeks pre-intervention, every day for 4 weeks during intervention, and every day for 4 weeks post-intervention to track their change in headache frequency, intensity, and impairment.
EMA will be used for repeated real-time sampling of headaches symptoms prior to intervention, during intervention, and after intervention. Participants will access the EMA application (app) on their personal smartphones.
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
The WHOQOL-BREF is a 26-item self-report assessment of quality of life and will be used to assess changes in QOL over the course of the study. Items are rated on a scale from 1 (very poor) to 5 (very good).
Migraine Disability Assessment (MIDAS)
Time frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
The MIDAS is a 5-item self-report assessment of headache disability and will be used to assess change in headache impairment over the course of the study. Participants are to respond with the number of days they have experienced various types of headache disability. The last question asks them to rate on a scale from 0 (no pain at all) to 10 (pain as bad as it can be).
Patient-Reported Outcomes Measurement Information System - Pain Interference - Short Form 6b (PROMIS-SF6b)
Time frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
The PROMIS-SF6b is a 6-item self-report assessment of pain interference and will be used to assess change in universal (non-headache specific) pain over the course of the study. Items are rated on a 5 point scale from "Not at all" to "Very Much".
8 secondary outcomes
Barratt Impulsiveness Scale - Version 11 (BIS-11)
Time frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Beck Anxiety Inventory (BAI)
Time frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
PTSD Checklist for DSM-V (PCL-5)
Time frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).
Dot Counting (Cognitive Task)
Time frame: The dot counting task will be administered at every stimulation visit during the 4 weeks of intervention (total of 12 times).
N-Back (Cognitive Task)
Time frame: The N-Back task will be administered at every stimulation visit during the 4 weeks of intervention (a total of 12 times).
Risk Task (Cognitive Task)
Time frame: The risk task will be administered at every stimulation visit during the 4 weeks of intervention ( a total of 12 times).
Caffeine and Nicotine Use Questionnaire
Time frame: Baseline and daily for 10 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: Undecided. Final data sets may be made available upon written request and subject to sponsor approval.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta Burst Stimulation in people with Post-Traumatic Headache and Transcranial Magnetic Stimulation, run by Minneapolis Veterans Affairs 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 14 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 28 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrina Friedrich (612-467-1811, katrina.friedrich@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ecological Momentary Assessment (EMA) for Headache Frequency, Intensity, and Impairment (time frame: Participants will take the daily headache assessment every day for 2 weeks pre-intervention, every day for 4 weeks during intervention, and every day for 4 weeks post-intervention to track their change in headache frequency, intensity, and impairment.). The study lists 4 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 28 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.