This single-center randomized controlled trial enrolled stroke patients with working memory impairment. Participants were randomly divided into the hyperbaric oxygen combined low-intensity focused ultrasound intervention group and the conventional rehabilitation control group. The intervention lasted for a fixed course, and indicators including working memory performance and prefrontal cortex activation detected by fNIRS were compared before and after treatment. The study aims to verify whether combined intervention can better improve cognitive function in stroke survivors. All subjects signed informed consent and obtained ethical approval before enrollment.
A prospective single-center randomized controlled study was conducted among inpatients with ischemic stroke complicated with working memory deficit admitted to the Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University from December 6, 2024 to May 1, 2025. Eligible participants were randomly allocated into two groups: the experimental group received hyperbaric oxygen therapy plus low-intensity focused ultrasound neuromodulation on the prefrontal cortex, while the control group received routine occupational therapy and cognitive rehabilitation training with equal treatment duration. The primary outcomes were 2-back task accuracy and reaction time assessed by neurobehavioral tests; secondary outcomes included oxygenated hemoglobin concentration in bilateral DLPFC monitored by functional near-infrared spectroscopy before intervention, after 2 weeks and after the full course. Demographic data, stroke lesion characteristics and adverse events were recorded synchronously. Statistical analysis adopted independent sample t-test and repeated-measures ANOVA to compare inter-group and intra-group differences. The whole research scheme was approved by the hospital ethics committee, and written informed consent was acquired from each participant before enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Routine physical rehabilitation including physical factor therapy, occupational therapy and basic motor training, 5 sessions per week, lasting for 14 consecutive days, no additional aerobic exercise or hyperbaric oxygen treatment.
Sitting stationary bicycle training: 4-minute warm-up, 15-minute moderate-intensity cycling (heart rate controlled at 60%-69% of predicted maximum heart rate), 3-minute relaxation after training; implemented 5 times weekly for 14 days, combined with conventional rehabilitation.
90-minute hyperbaric oxygen treatment under 2.0 ATA pressure, patients inhale pure oxygen through facial mask with short air breaks; 5 sessions weekly for 14 days, carried out together with conventional rehabilitation.
Moderate-intensity aerobic exercise and hyperbaric oxygen therapy are performed sequentially on the same day, combined with conventional rehabilitation, 5 sessions weekly for 14 consecutive days.
Wuhan Sixth Hospital
Wuhan, Hubei, China
2-back task working memory reaction time
Outcome assessors were blinded to group allocation. The reaction time of participants completing the 2-back cognitive task was recorded to quantify working memory performance before and after intervention among the four groups.
Time frame: Baseline (day 0), post-intervention (day 14)
Prefrontal cortical oxygenation level measured by fNIRS
Regional cerebral oxygen saturation of bilateral DLPFC was collected during cognitive tasks to reflect neural activation intensity.
Time frame: Baseline (day 0), post-intervention (day 14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.