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New treatment option for ADHD - Attention Deficit Disorder With Hyperactivity
Official title External Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder - Feasibility Trial
ClinicalTrials.gov ID: NCT06655610
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 17
You may be able to join if
- 7 to 17 years of age at the time of study enrollment.
- A clinical diagnosis of ADHD according to criteria for ICD-10: F90.0, F91.0, F90.8, F90.9, F98.8C. The ADHD diagnosis must be verified by the...
- A score above 24 on the ADHD rating scale (ADHD-RS) at baseline.
- Signed informed consent from parents/legal caretakers and from the patients aged ≥ 15. We will include treatment-naïve patients, patients who...
You likely can't join if
- Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together
- Epilepsy
- Electronic or metallic implants.
- Serious mental and/or somatic diseases other than ADHD, such as:
- Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9)
- Schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29)
See the full eligibility criteria
- 7 to 17 years of age at the time of study enrollment.
- A clinical diagnosis of ADHD according to criteria for ICD-10: F90.0, F91.0, F90.8, F90.9, F98.8C. The ADHD diagnosis must be verified by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) using The...
- A score above 24 on the ADHD rating scale (ADHD-RS) at baseline.
- Signed informed consent from parents/legal caretakers and from the patients aged ≥ 15. We will include treatment-naïve patients, patients who previously have received stimulant medication, and patients in stable...
- Patients receiving atomoxetine and guanfacine at the time of study enrollment will be excluded all together
- Epilepsy
- Electronic or metallic implants.
- Serious mental and/or somatic diseases other than ADHD, such as:
- Pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9)
- Schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29)
- Mania or bipolar disorder (ICD-10 F30 and F31)
- Depressive psychotic disorders (ICD-10 F32.3 + F33.3)
- Substance dependence syndrome (ICD-10 F1x.2)
- Cardio-vascular disorders
- Cancer
- An Intelligence quotient (IQ) below 70 measured by the Wechsler Intelligence Scale for Children
- A substantial degree of restless sleep as reported by parents or caregivers and evaluated by the physician.
- Other disabilities that may make use of Monarch problematic.
The study team makes the final eligibility decision.
Where it's taking place
- Slagelse, Region Sjælland, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Slagelse, Region Sjælland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.