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Corticosteroid
Mind and Body Approaches for Migraine
Phase 2
Recruiting
Led By Scott Powers, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders, 3rd Edition (beta) (ICHD-3b) criteria
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post treatment (8 weeks post randomization)
Awards & highlights
Study Summary
This trial is testing different treatments for migraines in children and young adults to see which work best. They will use things like fMRI and daily diary entries to track progress.
Who is the study for?
This trial is for young people with migraines, who have them 8-28 days a month and experience some disruption in daily life. They must be able to swallow pills, not take certain painkillers too often, and can't start new migraine prevention meds during the study. Participants need to fit in an MRI scanner and not have metal implants or severe claustrophobia.Check my eligibility
What is being tested?
The trial tests how well different treatments help youth with migraines by looking at brain scans, headache diaries, pain response tests, and questionnaires before/after treatment. Treatments include cognitive therapy (CBT), biofeedback training (BART), cognitive reappraisal (CR) training, amitriptyline (a medication), or placebo over 8 weeks.See study design
What are the potential side effects?
Amitriptyline may cause dry mouth, drowsiness, constipation or heart issues like QT interval lengthening on an ECG. CBT and BART are generally safe but could potentially lead to temporary discomfort from discussing personal issues or learning relaxation techniques.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with migraine, following the ICHD-3b criteria.
Select...
My daily activities are mildly to severely disrupted due to my condition.
Select...
I have had between 8 and 28 headaches in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post treatment (8 weeks post randomization)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post treatment (8 weeks post randomization)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in functional resonance imaging (fMRI)
Conditioned pain modulation as measured in a standard protocol using quantitative sensory testing. Employed as a predictor of headache day change in the study analytic plan
Side effects data
From 2018 Phase 4 trial • 95 Patients • NCT0104127418%
Weight increase
10%
Tachycardia
6%
Psychiatric Hospitalization
6%
Hypertension
6%
Loss of libido
4%
Concentration impaired
4%
Appetite increase
4%
Memory impaired
4%
Rash
4%
Restlessness
4%
Amenorrhea
2%
Dizziness upon standing
2%
Apathy
2%
Sleep disturbed
2%
Anorgasmia
2%
Blurred vision
2%
Drug abuse
2%
Akathisia
2%
Drooling
2%
Appetite decrease
2%
Drug-related hospitalization
2%
Cellulitis
2%
Hot flashes
2%
Medical Hospitalization
2%
Fatigue
2%
Hiccup
2%
Hit by a motorcycle
2%
Hurt when riding a bike
2%
Mental activity decreased
2%
Muscle twitch
2%
Sleeplessness
2%
Pneumonia
2%
Nightmares
2%
Teeth grating
2%
Incarceration
2%
Sensory hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citalopram
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cognitive Behavioral Therapy (CBT)Experimental Treatment1 Intervention
Cognitive Behavioral Therapy (CBT) is a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.
Group II: AmitriptylineActive Control1 Intervention
Amitriptyline will be administered once a day at home, to be taken by mouth. Dosage will be weight-based.
Group III: Biofeedback-Assisted Relaxation Training (BART)Active Control1 Intervention
Biofeedback-Assisted Relaxation Training (BART) is a mind and body based intervention that focuses specifically on mind and body techniques such as deep breathing, muscle relaxation, and guided imagery skills to manage pain.
Group IV: Cognitive Retraining (CR)Active Control1 Intervention
Cognitive Retraining (CR) is a mind and body based intervention that focuses on the use of tests of evidence and other cognitive strategies such as positive coping statements and pleasant activities and mindfulness to manage pain.
Group V: PlaceboPlacebo Group1 Intervention
The placebo pill will be administered once a day at home, to be taken by mouth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,381 Total Patients Enrolled
6 Trials studying Migraine
2,088 Patients Enrolled for Migraine
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,149 Total Patients Enrolled
7 Trials studying Migraine
1,027 Patients Enrolled for Migraine
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,718 Total Patients Enrolled
11 Trials studying Migraine
1,261 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh less than 30 kg or more than 120 kg, or your size is not suitable for an MRI scanner.I have been diagnosed with migraine, following the ICHD-3b criteria.I agree to limit my use of NSAIDs to less than 3 times a week and migraine medications to less than 6 times a month.You have a psychiatric condition like psychosis, bipolar disorder, or major depression, or a developmental delay like autism or ADHD that could make it difficult to follow the study rules or participate safely.My daily activities are mildly to severely disrupted due to my condition.I am not currently taking and agree not to start any migraine prevention medication during the study.Your initial electrocardiogram (ECG) shows a prolonged QT interval of 450 milliseconds or more.I have been diagnosed with epilepsy or another neurological condition.You are afraid of being in small or enclosed spaces.You have braces or metal implants that can't be in the MRI machine.I am currently taking opioids, antipsychotics, or similar medications.I have had between 8 and 28 headaches in the last 28 days.You have had a serious allergic reaction to amitriptyline in the past.I can speak English and complete forms or interviews in English.I cannot learn to swallow pills, even with training.I am a sexually active youth not using or planning to use birth control.I have had a non-stop headache for the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy (CBT)
- Group 2: Placebo
- Group 3: Amitriptyline
- Group 4: Biofeedback-Assisted Relaxation Training (BART)
- Group 5: Cognitive Retraining (CR)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How efficacious is Cognitive Behavioral Therapy for individuals?
"Based on our assessment, Cognitive Behavioral Therapy (CBT) has been rated at 2 due to the fact that Phase 2 clinical trials have not yet demonstrated any efficacy of this treatment but some level of safety."
Answered by AI
How many volunteers have joined this experiment?
"Affirmative. The clinical trial information hosted on clinicaltrials.gov confirms that this medical study, which was initially posted October 2nd 2018, is actively recruiting participants. 215 patients are needed from one single site to complete the research."
Answered by AI
Are recruitment efforts underway for this clinical trial?
"Data on clinicaltrials.gov reveals that this medical experiment is recruiting actively. It was first introduced to the public on October 2nd, 2018 and has been updated most recently as of February 7th, 2022."
Answered by AI
Are there any eligibility requirements to participate in this experimental trial?
"For this medical trial, 215 pediatric patients aged 10 to 17 with headache symptoms need to be enrolled. Specifically, they must have 8-28 occurrences of headaches in the past 28 days and a PedMIDAS Disability Score between 11 and 139."
Answered by AI
Does the trial necessitate a participant's age to be below or above twenty years?
"This trial is exclusively for patients aged between 10 and 17 years old. There are 45 other research studies targeting this age group, while 183 trials focus on people over 65."
Answered by AI
What psychological issues commonly respond favorably to Cognitive Behavioral Therapy (CBT)?
"Cognitive Behavioral Therapy is a common therapeutic approach used to address anorexia nervosa, as well as neuropathic pain, diabetic neuralgia and Major Depressive Disorder (MDD)."
Answered by AI
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