A randomised controlled trial comparing the effects of transcranial pulse stimulation and EEG neurofeedback on sustained attention and depressive symptoms in young adults.

BACKGROUND

Non-pharmacological interventions for sustained-attention difficulties in young adults remain limited. Transcranial pulse stimulation (TPS), a focused ultrasound-based neuromodulation technique, has shown preliminary promise in improving neuropsychiatric symptoms, but its effects on sustained attention in young adults are unclear. We therefore compared TPS with electroencephalography (EEG)-based theta-beta ratio (TBR) neurofeedback (NF) and a wait-list control (WLC) in young adults with subclinical sustained-attention difficulties.

METHODS

This single-centre, three-arm, parallel-group randomised controlled trial enrolled right-handed adults aged 20-34 years with subclinical sustained-attention difficulties. Participants were assigned to TPS, NF, or WLC. Both active interventions comprised 12 sessions over 4 weeks. Primary outcomes were performance indices from the Conners Continuous Performance Test, Third Edition (CPT-3), including detectability (d'), omission errors, commission errors, perseverations, hit reaction time (HRT), HRT standard deviation, reaction-time variability, HRT block change, and HRT interstimulus-interval change. Secondary outcomes included self-report measures of attentional control, psychological distress, anxiety, depression, self-esteem, social connectedness, and additional cognitive tasks. Outcomes were analysed using linear mixed-effects models with false discovery rate correction.

RESULTS

Fifty-seven participants were analysed (TPS = 22, NF = 12, WLC = 23; mean age = 24.2 years; 60% female). At post-treatment, TPS showed greater improvement than NF on 8 of 9 CPT-3 outcomes (false discovery rate-adjusted q = 0.001-0.033; Cohen's d = -0.93 to -1.61) and greater improvement than WLC on 5 of 9 CPT-3 outcomes (q = 0.001-0.031; d = -0.75 to -1.39). NF did not outperform WLC on any CPT-3 outcome. Among subjective-report outcomes, TPS showed a greater reduction in depressive symptoms than NF (Hospital Anxiety and Depression Scale-Depression, q = 0.028; d = -0.91), whereas no other between-group differences survived correction. No between-group differences in CPT-3 outcomes survived correction at 1- to 3-month follow-up. No serious adverse events occurred. Exploratory EEG analyses suggested successful modulation of the trained TBR target in the NF group, but this did not translate into measurable cognitive benefit.

CONCLUSIONS

TPS was associated with greater short-term improvement in sustained attention than NF or WLC in young adults with subclinical attention difficulties. However, durability remains uncertain because between-group effects were not maintained at follow-up. Larger, blinded, sham-controlled trials are needed to determine the specificity, clinical significance, and longer-term durability of TPS effects.