Efficacy of Trigeminal Nerve Stimulation for ADHD

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · May 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called external trigeminal nerve stimulation (TNS) for children with Attention-Deficit Hyperactivity Disorder (ADHD). TNS is a non-invasive method that involves placing a small device on the skin to send gentle electrical signals to a specific nerve in the face. The trial will involve 180 children aged 7 to 12 years, and it aims to determine whether TNS can effectively reduce ADHD symptoms over a 4-week period compared to a placebo (sham treatment). Researchers will also look at how brain activity relates to the treatment's effects and whether certain cognitive abilities can predict how well a child responds to TNS.

To be eligible for the study, children must be between 7 and 12 years old, have a diagnosis of ADHD, and meet specific criteria regarding their ADHD symptoms. Importantly, they should not be currently taking any medications that affect the central nervous system. Parents will play a key role by helping monitor the use of the device and completing necessary assessments. Participants can expect to attend several visits for evaluations, including a brain activity test called electroencephalography (EEG). This trial is actively recruiting participants, and it's a great opportunity for families looking for new treatment options for ADHD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. male and female children ages 7 to 12 years with DSM-5 ADHD, any current presentation, as determined by diagnostic interview, Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), and clinical interview;
• • 2. total score \>= 24 on baseline ADHD-RS;
• • 3. CGI-S score at baseline \>= 4;
• • 4. no current medication with CNS effects (Participants previously on psychostimulant medication will be required to be not optimally treated and off medication for one week or 5 half-lives for all other medications); stable use of supplements will be permitted;
• • 5. parents able and willing to monitor proper use of the stimulation device and complete all required rating scales;
• • 6. estimated Full Scale IQ \>= 80 based on WASI subtests;
• • 7. parent and participant able to complete rating scales and other measures in English;
• • 8. able to cooperate during EEG
• Exclusion Criteria:
• • 1. impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator;
• • 2. current diagnosis of autism spectrum disorder or major depression;
• • 3. history of lifetime psychosis, mania, or seizure disorder;
• • 4. baseline suicidality;
• • 5. history of seizure disorder or head injury with loss of consciousness