Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655610
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
External Trigeminal Nerve Stimulation Versus Sham Stimulation for Attention Deficit Hyperactivity Disorder in Children and Adolescents Aged 7-17 Years Study Protocol for a Pilot and Feasibility Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eTNS4ADHD
Brief Summary:
The investigators will assess the use of the Monarch eTNS device as a non-pharmacological treatment for patients aged 7 to 17 years with ADHD
The investigators will compare the eTNS device to a sham device Participants will use the device for four weeks during night time During the trial participants will receive different questionaires to assess symptoms and will also keep a logbook to record their experience with the device
At the end of trial the investigators will assess what the families thought of the device and whether it is indeed feasible to further explore the effect of the device in a larger clinical trial
The investigators will compare the eTNS device to a sham device Participants will use the device for four weeks during night time During the trial participants will receive different questionaires to assess symptoms and will also keep a logbook to record their experience with the device
At the end of trial the investigators will assess what the families thought of the device and whether it is indeed feasible to further explore the effect of the device in a larger clinical trial
Detailed Description:
External trigeminal nerve stimulation eTNS is a non-invasive technique involving external cutaneous stimulation of the trigeminal nerve In 2019 the Monarch eTNS device was approved as a treatment for children with attention-deficithyperactivity disorder ADHD The Monarch eTNS device is designed to be applied at home which offers a certain level of convenience but also necessitates a high degree of compliance and acceptability from the families
The objective of the present trial is to assess the feasibility of and pilot a larger randomized clinical trial investigating the Monarch eTNS device versus sham for patients aged 7 to 17 years with ADHD
The investigators will conduct a parallel-group sham-controlled feasibility randomised clinical trial The investigators will include 60 children and adolescents age 7 to 17 years diagnosed with ADHD from three clinical sites in Denmark Patients will be randomised to 4 weeks of active versus sham eTNS Feasibility outcomes include completion of the trial the number of eligible participants treatment compliance and completion Adverse events will be monitored throughout the trial Exploratory clinical outcomes include ADHD core symptoms primary and several secondary outcomes Autonomic functions will be evaluated by means of heart rate variability using a heart rate sensor
This trial will evaluate the feasibility of conducting a larger randomised clinical trial investigating the use of eTNS as a home-based non-pharmacological intervention for children and adolescents diagnosed with ADHD
The objective of the present trial is to assess the feasibility of and pilot a larger randomized clinical trial investigating the Monarch eTNS device versus sham for patients aged 7 to 17 years with ADHD
The investigators will conduct a parallel-group sham-controlled feasibility randomised clinical trial The investigators will include 60 children and adolescents age 7 to 17 years diagnosed with ADHD from three clinical sites in Denmark Patients will be randomised to 4 weeks of active versus sham eTNS Feasibility outcomes include completion of the trial the number of eligible participants treatment compliance and completion Adverse events will be monitored throughout the trial Exploratory clinical outcomes include ADHD core symptoms primary and several secondary outcomes Autonomic functions will be evaluated by means of heart rate variability using a heart rate sensor
This trial will evaluate the feasibility of conducting a larger randomised clinical trial investigating the use of eTNS as a home-based non-pharmacological intervention for children and adolescents diagnosed with ADHD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None