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Behavioural Intervention
Nerivio Device for New Daily Persistent Headache
N/A
Recruiting
Led By Marc DiSabella, DO
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants age 12-17 years old at the time of informed consent, inclusive.
Participants age 12-17 years old at the time of informed consent, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and at 1 month after initiation of treatment with ren
Awards & highlights
Study Summary
This trial is studying a device that sends electrical stimulation to the upper arm to try to relieve headaches in adolescents with new daily persistent headaches (NDPH).
Who is the study for?
This trial is for adolescents aged 12-17 with New Daily Persistent Headache (NDPH) who haven't responded well to standard treatments. They must have had NDPH for at least six months, be on stable headache prevention medication for three months, and can operate a smartphone. It's not open to those with implanted devices like pacemakers, severe heart conditions, epilepsy, recent nerve blocks or Botox in the head/neck area, current participation in other trials, cognitive/motor issues affecting smartphone use, pregnancy/breastfeeding status or an arm circumference below 7.9 inches.Check my eligibility
What is being tested?
The Nerivio device is being tested as a new treatment option for adolescent patients with NDPH. This non-drug therapy uses Remote Electrical Neuromodulation (REN) delivered through the upper arm to help relieve headaches by activating natural pain suppression pathways in the brain.See study design
What are the potential side effects?
While this study aims to confirm safety and effectiveness of Nerivio without unexpected adverse effects, potential side effects may include local discomfort where the device attaches or skin irritation from electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 17 years old.
Select...
I am between 12 and 17 years old.
Select...
I have had daily headaches for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and at 1 month after initiation of treatment with ren
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and at 1 month after initiation of treatment with ren
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disappearance of associated symptoms at 2 hours post-treatment
Functional disability at 2 hours post-treatment
Improve of quality of life assessed by PedsMIDAS questionnaire
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Participants will receive a device and will be asked to treat headaches with it and report in the app the characteristics of the attacks at the beginning of the attack as well as at 2 hours after the treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nerivio
2022
N/A
~340
Find a Location
Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
211 Previous Clinical Trials
208,057 Total Patients Enrolled
TheranicaIndustry Sponsor
19 Previous Clinical Trials
40,842 Total Patients Enrolled
Marc DiSabella, DOPrincipal InvestigatorChildren's National Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have epilepsy.I have severe heart or brain blood vessel disease.You have a device like a pacemaker or cochlear implant implanted in your body.I am willing and able to agree to participate in the study.I have not had a nerve block or Botox in my head/neck in the last 4 months.I have been on a stable dose of preventive medication for at least three months.I have been on a stable dose of preventive medication for at least 3 months.Your arm is smaller than 7.9 inches (20 cm) around.People who have used the device before.I am between 12 and 17 years old.I am between 12 and 17 years old.I have had daily headaches for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Who has the aptitude to take part in this experiment?
"This medical research project seeks to enrol 100 adolescents aged 12-17 with a minimum 6-month history of New Daily Persistent Headache. Qualified individuals must be able and willing to comply, have access to a smartphone, and obtain parental/guardian consent. Furthermore, they should already be taking prophylaxis medications for at least 3 months prior to joining the trial."
Answered by AI
Are there any vacancies left for participants in this medical experiment?
"Absolutely, the information available on clinicaltrials.gov displays that this experiment is presently accepting participants. The study was initially published on February 1st 2022 and has since been refreshed for April 4th of the same year. 100 applicants need to be enlisted from a single site."
Answered by AI
Is participation in this trial restricted to individuals aged 35 or younger?
"According to the requirements for enrollment, potential participants must be between 12 and 17 years old."
Answered by AI
What is the current sample size of this experiment?
"Affirmative, the information published on clinicaltrials.gov indicates that this medical study is presently recruiting participants. It was initially unveiled on February 1st 2022 and most recently refreshed on April 4th 2022. The trial seeks to enlist 100 individuals from a single site."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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