Post Traumatic HeadacheMBSR-PTHNCT02145117
Brain Biomarkers w/Mind-Body Tx in Veterans With Post Traumatic Headache (PTH)
A study testing MBSR in people with Post Traumatic Headache, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This project aims to develop and test structural and functional brain imaging biomarkers for improvement in chronic pain from a mind/body intervention perspective in a critical veteran population, namely veterans with post traumatic headache (PTH) associated with mild traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Post Traumatic Headache
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2013to 1 Apr 2016
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males and female veterans at least 18 years of age
- Mild post traumatic headaches, diagnosed by a physician
- No prior training in MBSR or other mindfulness or meditation training will be allowed
- Able to read and speak English
- No participation in a clinical trial within the last 28 days
Who cannot join
- Current severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder, claustrophobia, history of panic attacks)
- Significant co-morbid condition(s) such as insulin-dependent diabetes, cancer, obesity (BMI>35), severe lung disease, neurological conditions (e.g., seizures), uncontrolled hypertension, or significant heart disease
- History of persistent headaches prior to TBI
- Unsafe for MRI (e.g., metal objects/shrapnel, metallic implants, brain or skull abnormalities, and claustrophobia)
- Use of centrally acting medications that will interfere with the neuroimaging testing (e.g. narcotic medications)
- Daily use of illicit drugs or marijuana
- Daily alcohol consumption of greater than 2 units
Trial locations and contacts
1 site in 1 country.
United States1 site
VA West Los Angeles Medical Center
Los Angeles, California, 90073
About this study
Official title: Neuroimaging Biomarkers of Mind-Body Treatment in Veterans With Post Traumatic Headache (PTH)
This project aims to develop and test structural and functional brain imaging biomarkers for improvement in chronic pain from a mind/body intervention perspective in a critical veteran population, namely veterans with post traumatic headache (PTH) associated with mild traumatic brain injury (TBI). The project also aims to examine feasibility in a sample of veterans with PTH of performing resting state and structural neuroimaging protocols, and of obtaining active participation and completion of MBSR training. Lastly, exploratory analysis of brain imaging data will be performed to determine if hypothesized candidate biomarkers are associated with positive outcomes from MBSR and determine estimated effect sizes for future studies in PTH population.
Read the detailed description
Returning veterans from Iraq and Afghanistan (OIF/OEF veterans) have a very high incidence of TBI (14-23%) with the largest number having mild TBI (i.e., no discernible structural brain damage) with 63.5% having persistent headache. Treatment of PTH in this population has been difficult and mind/body interventions including Mindfulness Based Stress Reduction (MBSR) may offer significant benefit. A biomarker that will support clinical endpoints ("surrogate endpoint") and help predict clinical benefit, could be used to more efficiently and completely assess mind/body treatment effects in clinical trials for PTH, compare various complementary and alternative medicine (CAM) treatments, and potentially target specific treatments to patients most likely to benefit. This project aims to investigate candidate biomarkers for MBSR response in veterans with PTH. Primarily, all subjects if they are interested and appropriate for the study, will undergo a screening at their regular clinic visit at the VAGLAS physical medicine and rehab department. If a subject responds to advertisement they will be screened using the same tools and enrollment criteria required for the veterans at VAGLAS. We expect we will need to enroll and screen no less than 33 subjects in order to complete 20 evaluable subjects for analysis. The study subjects will be evaluated for the severity of their PTH, the impact of PTH on their life, and the extent of the disease/pain condition. If eligible the nurse coordinator will contact them to schedule the pre-MBSR functional MRI visit. At the MRI we will evaluate patterns of activity (functional connectivity) in the brain at rest, and look at cortical thickness. Following the MRI visit all subjects will complete a 9-week modified MBSR training with a qualified instructor. Mid-study (after MBSR class 4) the subject will be asked to complete mid-study questionnaires at home on Survey Monkey or on paper if they choose. At the end of the MBSR training in which the subject will have to complete at least 3 visits, functional (f)MRI procedure will be repeated and compared against the first. Three months after completing the study there will be a follow-up visit to complete behavioral/symptom/quality of life questionnaires on line via SurveyMonkey. This is to see if the changes in the biomarkers will mediate changes in these behavioral measures 3-mo post Treatment (i.e. measure stability).
All in all, to complete the study subjects will have a screening visit, pre and post training MRI visit, up to 9 MBSR training visits, mid study questionnaires, a 4-hr retreat visit after week 6 and a final 3-mo f/u visit for questionnaires only.
- Conditions
- Post Traumatic Headache
- Being tested
- MBSR
- Keywords
- MBSR, fMRI, PTH
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Also called Mindfullness Based Stress Reduction Training
Behavioral
| Study group | Role | What they receive |
|---|---|---|
| MBSR Training | Other | Mindfulness Based Stress Reduction (MBSR) Training Receives: Behavioral: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate Optimal Biomarker candidates
To validate optimal brain biomarker candidates by assessment of treatment responsiveness in post traumatic headache following a 9 week course in Mindfulness Based Stress Reduction (MBSR)
Measured: After MBSR training (9 weeks)
Secondary outcomes (1)
Specificity, generality and moderation of biomarker response to MBSR treatment
Specificity of biomarker response to MBSR measured by changes in selected biomarker candidates correlation with improvement in mindfulness at end of treatment and 3-month follow-up.
Determine generality of optimal biomarkers via examination of factors such as sex, age, co-morbid pain, mood, and/or baseline severity, as moderators of biomarker performance.
Measured: Post MBSR training at 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start1 Sep 2013
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
Why it stopped: unable to recruit sufficent subjects
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.
- More trials run by University of California, Los AngelesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- unblinded
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- VA Medical Center-West Los Angeles, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Kirsten Tillisch, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145117
- Sponsor's protocol ID
- 13-000864
- Other IDs
- R01AT007137
- Acronym
- MBSR-PTH
- Status last verified
- Dec 2017
- First submitted
- 20 May 2014
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Biomarkers of Mind-Body Treatment in Veterans With Post Traumatic Headache (PTH)
- ClinicalTrials.gov ID
- NCT02145117
- Acronym / sponsor ID
- MBSR-PTH / 13-000864
- Conditions
- Post Traumatic Headache
- Keywords
- MBSR, fMRI, PTH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to recruit sufficent subjects
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- VA Medical Center-West Los Angeles, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 22 May 2014 (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.
This project aims to develop and test structural and functional brain imaging biomarkers for improvement in chronic pain from a mind/body intervention perspective in a critical veteran population, namely veterans with post traumatic headache (PTH) associated with mild traumatic brain injury (TBI). The project also aims to examine feasibility in a sample of veterans with PTH of performing resting state and structural neuroimaging protocols, and of obtaining active participation and completion of MBSR training. Lastly, exploratory analysis of brain imaging data will be performed to determine if hypothesized candidate biomarkers are associated with positive outcomes from MBSR and determine estimated effect sizes for future studies in PTH population.
Detailed description
Returning veterans from Iraq and Afghanistan (OIF/OEF veterans) have a very high incidence of TBI (14-23%) with the largest number having mild TBI (i.e., no discernible structural brain damage) with 63.5% having persistent headache. Treatment of PTH in this population has been difficult and mind/body interventions including Mindfulness Based Stress Reduction (MBSR) may offer significant benefit. A biomarker that will support clinical endpoints ("surrogate endpoint") and help predict clinical benefit, could be used to more efficiently and completely assess mind/body treatment effects in clinical trials for PTH, compare various complementary and alternative medicine (CAM) treatments, and potentially target specific treatments to patients most likely to benefit. This project aims to investigate candidate biomarkers for MBSR response in veterans with PTH. Primarily, all subjects if they are interested and appropriate for the study, will undergo a screening at their regular clinic visit at the VAGLAS physical medicine and rehab department. If a subject responds to advertisement they will be screened using the same tools and enrollment criteria required for the veterans at VAGLAS. We expect we will need to enroll and screen no less than 33 subjects in order to complete 20 evaluable subjects for analysis. The study subjects will be evaluated for the severity of their PTH, the impact of PTH on their life, and the extent of the disease/pain condition. If eligible the nurse coordinator will contact them to schedule the pre-MBSR functional MRI visit. At the MRI we will evaluate patterns of activity (functional connectivity) in the brain at rest, and look at cortical thickness. Following the MRI visit all subjects will complete a 9-week modified MBSR training with a qualified instructor. Mid-study (after MBSR class 4) the subject will be asked to complete mid-study questionnaires at home on Survey Monkey or on paper if they choose. At the end of the MBSR training in which the subject will have to complete at least 3 visits, functional (f)MRI procedure will be repeated and compared against the first. Three months after completing the study there will be a follow-up visit to complete behavioral/symptom/quality of life questionnaires on line via SurveyMonkey. This is to see if the changes in the biomarkers will mediate changes in these behavioral measures 3-mo post Treatment (i.e. measure stability).
All in all, to complete the study subjects will have a screening visit, pre and post training MRI visit, up to 9 MBSR training visits, mid study questionnaires, a 4-hr retreat visit after week 6 and a final 3-mo f/u visit for questionnaires only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- unblinded
| Arm | Type | Receives |
|---|---|---|
| MBSR Training | Other | Behavioral: MBSRMindfulness Based Stress Reduction (MBSR) Training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and female veterans at least 18 years of age
- Mild post traumatic headaches, diagnosed by a physician
- No prior training in MBSR or other mindfulness or meditation training will be allowed
- Able to read and speak English
- No participation in a clinical trial within the last 28 days
Key exclusion criteria (7 listed)
- Current severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder, claustrophobia, history of panic attacks)
- Significant co-morbid condition(s) such as insulin-dependent diabetes, cancer, obesity (BMI>35), severe lung disease, neurological conditions (e.g., seizures), uncontrolled hypertension, or significant heart disease
- History of persistent headaches prior to TBI
- Unsafe for MRI (e.g., metal objects/shrapnel, metallic implants, brain or skull abnormalities, and claustrophobia)
- Use of centrally acting medications that will interfere with the neuroimaging testing (e.g. narcotic medications)
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 |
|---|---|---|
| MBSRAlso: Mindfullness Based Stress Reduction TrainingBehavioral | Behavioural | MBSR Training |
Primary outcome
Validate Optimal Biomarker candidates
Time frame: After MBSR training (9 weeks)
To validate optimal brain biomarker candidates by assessment of treatment responsiveness in post traumatic headache following a 9 week course in Mindfulness Based Stress Reduction (MBSR)
1 secondary outcome
Specificity, generality and moderation of biomarker response to MBSR treatment
Time frame: Post MBSR training at 3 month follow up
Results and safety
The study was stopped early (reason given: unable to recruit sufficent subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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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.
Kirsten Tillisch, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR in people with Post Traumatic Headache, run by University of California, Los Angeles 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 Aug 2026. 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 was stopped early (reason given: unable to recruit sufficent subjects). Results are not available in the source record.
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?
Validate Optimal Biomarker candidates (time frame: After MBSR training (9 weeks)). 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 3 Aug 2026.