Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05310227
Status:
RECRUITING
Last Update Posted:
2023-09-05
First Post:
2022-03-21
Brief Title:
Nerivio Device for Treatment of New Daily Headache Persistence NDHP
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
A Prospective Single Arm Open Label Study of the Safety and Efficacy of Nerivio for the Acute Treatment of New Daily Headache Persistence NDHP in Adolescents
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to examine the effects of the Remote Electrical Neuromodulation REN device on adolescents ages 12-17 who have been diagnosed with New Daily Persistent Headache NDPH Pediatric patients with a diagnosis of new daily persistent headache are typically resistant to standard pharmacologic treatments and often experience systemic side effects related to medications thus REN offers the potential for an exciting new treatment option for patients with refractory headache disorders The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation CPM that activates a descending endogenous analgesic mechanism Ultimately the investigators hope to gain insights into the safety and efficacy of Nerivio for the acute treatment of NDPH in adolescents The goal of this study is to demonstrate headache relief without unexpected device-related adverse effects
Detailed Description:
This is a research study to evaluate a new non-invasive drug-free acute treatment of headache in adolescents aged 12-17 years old Participants are being asked to take part in this study because they suffer from persistent headaches
Device description
The device is a wireless wearable battery-operated stimulation unit controlled by a dedicated smartphone application Treatments with Nerivio are self-administered by the user at the onset of a headache The Nerivio includes several main components
A pair of electrodes covered with hydrogel and a removeable protective film
An electronic circuitry and a battery
A software that includes firmware and a software application for mobile platforms
An armband to secure the attachment of the device and enable a discreet treatment
Procedures and duration of participation
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 The study includes 3 visits to the clinic The investigators expect that participants will be in this research study for 8 weeks
Why is this research study being done
Participants are being asked to be in the study because they suffer from persistent headaches
The Nerivio device is approved by the FDA for acute treatment of migraine with or without aura in patients 12 years of age or older The purpose of this study is to assess the effect of the Nerivio device for treating New Daily persistent Headache NDPH in children The Nerivio is a non-invasive device operated via a smartphone application that changes brain activity The device is worn on the upper arm and the treatment is self-administered at the headache onset The device delivers non-painful electrical pulses to the skin that stimulate the body to initiate a pain inhibition mechanism in the brain During the treatment the users can adjust the intensity of the pulses according to how they tolerate it
Marc DiSabella is the person responsible for this research study at Childrens National He is called the Principal Investigator
What will happen in this research study
Each participant will receive a device to be used at home for the acute treatment of their headaches The device produces electrostimulation parameters aimed to relief headache pain In addition an app will be installed on the participants smartphone to control the device and record their headaches and their feedback regarding the effect of the device on their headaches
Schedule of What the participants will do
Enrollment Visit 1 Day 0
Arrive to Childrens National Medical Center with one of their parents for their scheduled appointment Bring packages of any medications that they are taking for any medical condition
Eligibility assessment
Meet with Dr DiSabella or one of the colleagues andor the study team to answer questions about their general health and their headaches
If this form is received today the participant and their parents can take time to read it carefully and make sure all of their questions and concerns are answered
The participant may request another appointment in case they would like to read this form at home and consult with family members or friends
If the participant is a girl and have had their first period they will provide a urine sample for a pregnancy test
If the participant agree to participate a member of the study staff will install the app on their smartphone The investigators will provide an explanation on how to operate the smartphone application
the investigators will train the participant on how to complete their headache diary
Run-in phase Days 1-28
Complete the diary whenever the participant experience a new headache
The study staff will contact the participant to schedule their next visit
Device training Visit Day 29-37
Eligibility to continue in the study will be assessed based on their reports and compliance in the run-in phase
The participant will receive a device
The investigator will train the participant how to use the device and find the intensity level that is best for them
The participant can ask us any questions
The participant will take the Nerivio home with them
Treatment phase Day 1-28 following visit 2
Always have the device and their smartphone available
Use the device for the treatment of their headache onset and always with 60 minutes of onset and avoid taking rescue medication from the time of symptoms onset until 2 hours from treatment start 75 minutes from the end of the treatment Report the 2-hour post treatment feedback through the smartphone application
The application will ask the participant to rate their headache pain level at the beginning of the treatment after 2 hours and after 24 hours post treatment on a scale of 0-3 0 no pain 1 mild 2 moderate 3 severe
Call the study team if there is any change in their medical condition
At the end of this phase the participant will be contacted by a member of the study team to schedule their next visit
End of study visit 3 Please arrive to Childrens National Medical Center for their scheduled appointment complete the study questionnaires if required and return the device
Device description
The device is a wireless wearable battery-operated stimulation unit controlled by a dedicated smartphone application Treatments with Nerivio are self-administered by the user at the onset of a headache The Nerivio includes several main components
A pair of electrodes covered with hydrogel and a removeable protective film
An electronic circuitry and a battery
A software that includes firmware and a software application for mobile platforms
An armband to secure the attachment of the device and enable a discreet treatment
Procedures and duration of participation
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 The study includes 3 visits to the clinic The investigators expect that participants will be in this research study for 8 weeks
Why is this research study being done
Participants are being asked to be in the study because they suffer from persistent headaches
The Nerivio device is approved by the FDA for acute treatment of migraine with or without aura in patients 12 years of age or older The purpose of this study is to assess the effect of the Nerivio device for treating New Daily persistent Headache NDPH in children The Nerivio is a non-invasive device operated via a smartphone application that changes brain activity The device is worn on the upper arm and the treatment is self-administered at the headache onset The device delivers non-painful electrical pulses to the skin that stimulate the body to initiate a pain inhibition mechanism in the brain During the treatment the users can adjust the intensity of the pulses according to how they tolerate it
Marc DiSabella is the person responsible for this research study at Childrens National He is called the Principal Investigator
What will happen in this research study
Each participant will receive a device to be used at home for the acute treatment of their headaches The device produces electrostimulation parameters aimed to relief headache pain In addition an app will be installed on the participants smartphone to control the device and record their headaches and their feedback regarding the effect of the device on their headaches
Schedule of What the participants will do
Enrollment Visit 1 Day 0
Arrive to Childrens National Medical Center with one of their parents for their scheduled appointment Bring packages of any medications that they are taking for any medical condition
Eligibility assessment
Meet with Dr DiSabella or one of the colleagues andor the study team to answer questions about their general health and their headaches
If this form is received today the participant and their parents can take time to read it carefully and make sure all of their questions and concerns are answered
The participant may request another appointment in case they would like to read this form at home and consult with family members or friends
If the participant is a girl and have had their first period they will provide a urine sample for a pregnancy test
If the participant agree to participate a member of the study staff will install the app on their smartphone The investigators will provide an explanation on how to operate the smartphone application
the investigators will train the participant on how to complete their headache diary
Run-in phase Days 1-28
Complete the diary whenever the participant experience a new headache
The study staff will contact the participant to schedule their next visit
Device training Visit Day 29-37
Eligibility to continue in the study will be assessed based on their reports and compliance in the run-in phase
The participant will receive a device
The investigator will train the participant how to use the device and find the intensity level that is best for them
The participant can ask us any questions
The participant will take the Nerivio home with them
Treatment phase Day 1-28 following visit 2
Always have the device and their smartphone available
Use the device for the treatment of their headache onset and always with 60 minutes of onset and avoid taking rescue medication from the time of symptoms onset until 2 hours from treatment start 75 minutes from the end of the treatment Report the 2-hour post treatment feedback through the smartphone application
The application will ask the participant to rate their headache pain level at the beginning of the treatment after 2 hours and after 24 hours post treatment on a scale of 0-3 0 no pain 1 mild 2 moderate 3 severe
Call the study team if there is any change in their medical condition
At the end of this phase the participant will be contacted by a member of the study team to schedule their next visit
End of study visit 3 Please arrive to Childrens National Medical Center for their scheduled appointment complete the study questionnaires if required and return the device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None