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Neurobiological Mechanisms for Chronic Pain

N/A

Recruiting

Led By Sarah Nelson

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between ages 11-17 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4-month follow-up

Awards & highlights

Study Summary

This trial looks at the neurobiological mechanisms of pediatric chronic pain to help inform future treatments.

Who is the study for?

This trial is for young people aged 11-17 with chronic widespread pain, referred to the Boston Children's Hospital Pain Treatment Service. Participants must be right-handed and speak English well enough to complete questionnaires. They can't join if they have severe cognitive issues, take certain medications like steroids or psychotropics, have other chronic pain conditions, or can't undergo fMRI due to metal in their body.Check my eligibility

What is being tested?

The study is looking at how stress affects the bodies and brains of youths with chronic pain by measuring their 'allostatic load' (a stress marker) and observing brain activity using functional Magnetic Resonance Imaging (fMRI).See study design

What are the potential side effects?

There are no direct side effects from the interventions being studied as allostatic load measurement involves non-invasive tests and fMRI is a safe imaging technique that doesn’t use radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 11 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Blood Pressure

Change in Body-Mass Index (BMI)

Change in Dehydroepiandrosterone (DHEA)

+5 more

Secondary outcome measures

Change in Functional Disability

Change in Pain Intensity

Change in Sleep

Other outcome measures

Change in Adverse Childhood Experiences (ACEs) exposure

Change in Anxiety

Change in Depression

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study ArmExperimental Treatment2 Interventions

All participants enrolled in the study will undergo baseline fMRI and baseline and follow-up (4-month post-baseline) assessment of stress physiology (i.e., allostatic load). Treatment as usual information will be gathered for all participants to assess observational intervention response.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

functional Magnetic Resonance Imaging (fMRI)

2017

N/A

~140

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,660 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,863 Total Patients Enrolled

Sarah NelsonPrincipal Investigator - Boston Children's Hospital/Harvard Medical School

Boston Children's Hospital

Media Library

Study Arm Clinical Trial Eligibility Overview. Trial Name: NCT04488757 — N/A

Stress Clinical Trial 2023: Study Arm Highlights & Side Effects. Trial Name: NCT04488757 — N/A

Study Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04488757 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are members of the younger demographic eligible to participate in the experiment?

"This research is recruiting participants aged between 11 to 17 years of age."

Answered by AI

What are the criteria for potential participants in this clinical study?

"This clinical trial will accept 70 minors aged 11-17 who are suffering from chronic pain. To be eligible, participants must meet the criteria of being right handed and referred to Boston Children's Hospital Pain Treatment Service for a condition with duration greater than 3 months."

Answered by AI

Is enrollment into this research project still available?

"Yes, the latest information from clinicaltrials.gov shows that this trial is actively recruiting participants with a target of 70 individuals across 1 site. This research was posted on November 4th 2021 and updated for the last time on the same day."

Answered by AI

How many participants are currently included in this experiment?

"Yes, according to the information shared on clinicaltrials.gov this clinical trial is actively enrolling patients with a target of 70 individuals at 1 site. The study was originally posted and last edited on November 4th 2021."

Answered by AI

Who else is applying?

What site did they apply to?

Boston Children's Hospital

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have had 3 back surgeries 3 years in a row and the last one was 21/2 years ago for severe scoliosis . I had fusion on my lower back and I am not any better. I am in excruciating pain every single day. I haven’t had any relief at all.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain

Sarah Nelson 2021. "Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04488757.

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