Poststroke cognitive impairment (PSCI) has an incidence rate ranging from 24% to 80.97%. It reduces survival rates and increases disability among stroke patients, posing a substantial socioeconomic burden. Current treatments for PSCI primarily involve medication and rehabilitation; however, therapeutic efficacy remains limited, with unsatisfactory improvement in activities of daily living. This study aims to conduct a prospective clinical trial to evaluate the safety and efficacy of 40-Hz sensory stimulation-induced gamma oscillations in the treatment of PSCI, including assessment of neuropsychology, psychiatric symptoms, cerebral blood perfusion, and functional and structural brain changes, and to investigate the underlying mechanisms by RNA-sequencing of blood samples. This trial is designed as a prospective, randomized controlled, double-blind, non-inferiority study conducted in the Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine in China. Participants with confirmed cognitive impairment occurring after the stroke event and persisting for 3 to 6 months will be screened and recruited by the attending neurologists for participation. A total of 120 enrolled patients will be randomly assigned to one of two groups at a ratio of 1:1. The experimental group will receive 40-Hz sensory stimulation, while the control group will receive sensory stimulation at random frequencies. Both groups will receive the same standard clinical drug therapy and rehabilitation treatment. The primary efficacy endpoints include cognitive function and learning ability. Secondary endpoints encompass changes in cerebral hemodynamics, neural network connectivity, synaptic-related gene expression, and neurotransmitter levels. Safety assessments will include monitoring of major adverse events, all-cause mortality, and photosensitive epilepsy. Evaluations will be conducted at baseline, after the 14-day treatment period, and during follow-up visits (at 3 and 6 months). Differences between the two groups will be compared. This study will assess the safety and efficacy of gamma oscillations induced by 40-Hz sensory stimulation in treating PSCI patients. In parallel, potential mechanisms—including alterations in synaptic-related genes and neural network connectivity—will be explored. This trial is expected to provide evidence supporting the effectiveness of this novel technique for treating PSCI and improving patients’ quality of life. Chinese Clinical Trial Registry (ChiCTR) ChiCTR2400088535. Registered on 20 August 2024.
Fu et al. (2026) studied this question.