ADHD EEG Pilot Study

Study Design

A single-arm, open-label study of AKL-T01* in 28 children aged 8-12 years old, assessing mid-frontal theta (MFT) power measured by stimulus-locked electroencephalogram (EEG) following 4 weeks of at-home AKL-T01 treatment. All participants were off all ADHD medication at time of enrollment and for the duration of the study. The study was conducted at one site in the US.

Treatment

Subjects were instructed to complete approximately 25 minutes of AKL-T01 per day, 5 days per week for 4 weeks. 

Objectives: To explore whether subjects demonstrated enhancement of MFT power measured by stimulus-locked EEG after 4-weeks of at-home AKL-T01 treatment

Results

General MFT improvements were observed in children post-treatment. There was a significant main effect of session, (F(1,21) = 4.76, p = 0.04, d=0.44), suggesting that there was a general increase in MFT following the intervention (Figure a).

In analyses examining each 120 ms composite window separately there were significant increases in the early (0-120 ms: F(1,21) = 7.53, p = 0.01, d = 0.62) and late (760-880 ms: F(1,21) = 4.51, p = 0.046, d = 0.52) time windows. There was a numerical increase in MFT activity at the peak time period of 160-280 ms following stimulus onset, however this change did not reach significance (F(1,21) = 0.82, p = 0.38, d = 0.19)(Figure b).

Safety and Compliance

There were no treatment-related adverse events. Treatment compliance was excellent. Participants completed 100% ± 20% of expected missions.

*EndeavorOTC was previously known as AKL-T01 during the clinical investigations.