Stroke, Cognitive Impairment
Conditions
Keywords
stroke, working memory, hyperbaric oxygen therapy, functional near-infrared spectroscopy, aerobic exercise
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALConventional rehabilitation therapy
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.
BEHAVIORALModerate-intensity aerobic exercise
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.
BEHAVIORALHyperbaric Oxygen Therapy (HBOT)
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.
BEHAVIORALCombined aerobic exercise and hyperbaric oxygen therapy
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.
Sponsors
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blind design: only the outcome assessors who conducted cognitive tests, fNIRS scanning and blood index detection were blinded to group allocation. Participants, rehabilitation therapists and researchers were unblinded due to distinguishable intervention modes.
Intervention model description
This is a single-center 4-arm parallel randomized controlled trial. Participants with stroke and working memory impairment were randomly allocated into 4 groups: conventional rehabilitation control group, moderate-intensity aerobic exercise group, hyperbaric oxygen therapy group, combined hyperbaric oxygen + aerobic exercise group. A total of 50 subjects were enrolled and completed the 14-day intervention course.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* First-ever ischemic stroke confirmed by cranial MRI/CT; * Age 65-85 years old; * MoCA score 18-26 points (mild cognitive impairment after stroke); * Right-handed, able to complete 2-back cognitive task and fNIRS detection; * Signed written informed consent voluntarily.
Exclusion criteria
* History of dementia, traumatic brain injury or other central nervous system diseases; * Severe visual/auditory impairment unable to finish cognitive assessment; * Contraindications for hyperbaric oxygen therapy (untreated pneumothorax, severe emphysema etc.); * Severe cardiac insufficiency or unstable vital signs; * Taking cognitive improvement drugs within 1 month before enrollment; * Dropping out voluntarily during the 14-day intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-back task working memory reaction time | Baseline (day 0), post-intervention (day 14) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prefrontal cortical oxygenation level measured by fNIRS | Baseline (day 0), post-intervention (day 14) | Regional cerebral oxygen saturation of bilateral DLPFC was collected during cognitive tasks to reflect neural activation intensity. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWeixiang Qin, PhD
Wuhan Sixth Hospital
Outcome results
None listed