drugset / Trial / NCT03472092

Mind and Body Approaches to Pain Reduction in Youth With Migraine

NCT03472092

RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start
2018-10-02
Primary completion
2025-02-24
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amitriptyline Small molecule 1 mg/kg Oral

Indications