ADHD Treatment Device Falls Short in New Study

A device approved by the FDA for treating ADHD in children has been found ineffective in a recent clinical trial. The external trigeminal nerve stimulator, which was expected to reduce ADHD symptoms, showed no significant improvement compared to a placebo.

Key Findings

• Initial Approval: The FDA had initially approved the device based on a smaller trial with issues in its placebo conditions.
• New Study: Published in Nature Medicine, the new study involved 150 children and teenagers and used a more rigorous placebo method.
• Results: The device did not work better than the placebo.

How the Device Works

The device works by placing electrodes on the forehead while the child sleeps. These electrodes stimulate the trigeminal nerve, which is believed to affect brain regions linked to ADHD. However, the new study found that the treatment did not reduce ADHD symptoms.

Safety and Side Effects

• Safety: The treatment is safe and has no serious side effects.
• Effectiveness: However, it does not work as intended.

Importance of Rigorous Trials

The researchers emphasized the importance of designing appropriate placebo conditions in clinical trials to avoid false hopes. The study included a wider range of participants, including adolescents, which is important because long-term medication adherence is a challenge for this group.

Impact on Decision-Making

The researchers hope that this study will help parents and doctors make informed decisions about ADHD treatments. The study highlights the need for rigorous evidence to support shared decision-making regarding ADHD interventions. It is crucial for individuals with ADHD and their families to know which treatments work and which do not.