Overview

Mind and Body Approaches to Pain Reduction in Youth With Migraine

Status:
Recruiting
Trial end date:
2023-06-02
Target enrollment:
Participant gender:
Summary
The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily headache diaries, assessment of conditioned pain modulation via quantitative sensory testing, and validated psychometric assessments before and after the delivery of one of five treatments over an 8 week period [cognitive behavioral therapy (CBT), biofeedback-assisted relaxation training (BART) and cognitive reappraisal (CR) training, amitriptyline, and placebo]. We are examining both distinct and common pathways that may help explain the response to various preventive treatments, as well as potential predictors of outcome.
Phase:
Phase 2
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Treatments:
Amitriptyline
Amitriptyline, perphenazine drug combination