Mind and Body Approaches to Pain Reduction in Youth With Migraine

• Status: Recruiting
• Trial end date: 2023-06-02
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders, 3rd Edition (beta) (ICHD-3b) criteria

• Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 8 and ≤ 28

• PedMIDAS: PedMIDAS Disability Score > 10, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy

• English speaking: able to complete interviews and questionnaires in English

Exclusion Criteria:

• Continuous migraine defined as an unrelenting headache for a 28 day period

• Weight less than 30 kg or greater than 120 kg, or weight/size incompatible with magnetic resonance imaging (MRI) scanner

• Must agree not to take non-specific acute medication, such as nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month

• No current prophylactic anti-migraine medication within a period equivalent to < 5 half-lives of that medication before entering the screening phase, and agree to not begin a migraine prevention medication during the study period

• Current use of the following medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals

• Known history of allergic reaction or anaphylaxis to amitriptyline

• Abnormal findings on electrocardiogram (ECG) at baseline, particularly lengthening of the QT interval ≥ 450 msec

• Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment

• Claustrophobia

• Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)

• Diagnosis of epilepsy or other neurological diseases

• Inability to learn how to swallow pills using behavioral techniques (if indicated)

• Present psychiatric disease as defined by the Diagnostic and Statistical Manual (DSM) IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, attention deficit hyperactivity disorder (ADHD), or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study