Trial results for a real-world analysis of Remote Electrical Neuromodulation (REN) for acute treatment of Migraine in pre-adolescents were posted on ClinicalTrials.gov on 2025-09-15, indicating 0 device-related adverse events among the participants.
Background
Migraine is a common neurological disorder that significantly affects children and adolescents, leading to considerable disability. Remote Electrical Neuromodulation (REN) is a non-pharmacological, prescribed, wearable device that has received FDA clearance for the acute and/or preventive treatment of migraine in patients aged 12 years or older. Previous studies have demonstrated REN's high safety, tolerability, and efficacy in adult and adolescent populations. This specific study aimed to evaluate the real-world safety and efficacy of REN in a younger cohort, pre-adolescents aged 6-11 years.
Trial design
This completed study, titled "Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)", enrolled 293 participants with Migraine. The trial focused on evaluating the safety and efficacy of the Remote Electrical Neuromodulation (REN) device in pre-adolescents aged 6-11 years.
Key results
The trial results, focusing on the pre-adolescent group with migraine, included the following key measurements:
- The rate of device-related adverse events was reported as 0 participants.
- The number of participants achieving consistent headache relief at 2 hours post-treatment was 13.
- The number of participants achieving consistent freedom from headache at 2 hours post-treatment was 9.
- The number of participants achieving consistent migraine-associated symptoms disappearance at 2 hours post-treatment was 7.
- The number of participants achieving consistent migraine-associated symptoms disappearance at 2 hours post-treatment was 2.
- The number of participants achieving consistent migraine-associated symptoms disappearance at 2 hours post-treatment was 4.
- The number of participants achieving consistent migraine-associated symptoms disappearance at 2 hours post-treatment was 7.
- The number of participants achieving consistent functional disability relief at 2 hours post-treatment was 15.
- The number of participants achieving consistent functional disability disappearance at 2 hours post-treatment was 7.
What this means
The finding of 0 device-related adverse events in 293 pre-adolescent participants (6-11 years old) using Remote Electrical Neuromodulation (REN) for acute migraine treatment is a significant safety signal. This suggests that the device may be well-tolerated in this younger population, which is crucial for non-pharmacological interventions in pediatric care. While specific efficacy rates are reported for headache relief, freedom from headache, symptom disappearance, and functional disability, the primary implication from these results is the strong safety profile observed in this real-world analysis for pre-adolescents with migraine.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06138756, titled "Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)", were posted on 2025-09-15 on clinicaltrials.gov.