Brain Biomarkers w/Mind-Body Tx in Veterans With Post Traumatic Headache (PTH)

NCT02145117 | Unknown

• 2 other identifiers: 13-000864R01AT007137
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Post Traumatic Headache

Keywords

MBSR; fMRI; PTH

Outcome Measures

Primary Outcomes (1)

• 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)

  After MBSR training (9 weeks)

Secondary Outcomes (1)

• Specificity, generality and moderation of biomarker response to MBSR treatment

  Post MBSR training at 3 month follow up

Study Arms (1)

MBSR Training

OTHER

Mindfulness Based Stress Reduction (MBSR) Training

Behavioral: MBSR

Interventions

MBSR BEHAVIORAL

Behavioral

Also known as: Mindfullness Based Stress Reduction Training

MBSR Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• VA Medical Center-West Los Angeles: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

VA West Los Angeles Medical Center

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kirsten Tillisch, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: September 1, 2013
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

US (1)