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The efficacy and brain network mechanisms of transcranial focused ultrasound combined with mindfulness-integrated cognitive behavioral therapy for breast cancer-related cognitive dysfunction

The efficacy and brain network mechanisms of transcranial focused ultrasound combined with mindfulness-integrated cognitive behavioral therapy for breast cancer-related cognitive dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108493
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Education and Science Popularization Group:Receive nursing education and guidance, 5 times per week, 30 minutes per session
trained nurses should introduce patients to the symptoms, incidence, and impact of CRCI on their physical condition and daily life during rounds, and inform them of how to cope with the situation. Int
MICBT group:MICBT specifically includes 10 minutes of memory training and multisensory training, 10 minutes of physical training, and 10 minutes of mindfulness-based stress reduction therapy and music
tFUS group:The tFUS group received tFUS treatment, 5 times/week, 30 minutes/session, using low-frequency 2 MHz tFUS with an intensity below 720 mW/cm2 to stimulate the dorsolateral prefrontal cortex (
MICBT combined with tFUS group:Received MICBT and Tfus treatment. Five times per week, 60 minutes per session.

Sponsors

Shanghai Jing'an District Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1 First diagnosis of breast cancer at stage 2, having undergone modified radical mastectomy, chemotherapy, radiotherapy, and endocrine therapy, with endocrine therapy completed; chemotherapy, radiotherapy, and endocrine therapy regimens and medications were identical, and endocrine therapy was completed within the past year; 2 Age 30–55 years at enrollment, with no evidence of disease recurrence; 3 Able to undergo <= 150 minutes of low- to moderate-intensity cognitive and physical training and transcranial ultrasound therapy per week; 4 Patients' neuropsychological test scores after chemotherapy were reduced by at least one standard deviation (SD) compared to pre-chemotherapy levels; 5 Able to proficiently use Mandarin Chinese and willing to be randomly assigned to any group. Neuropsychological tests include the Hopkins Verbal Learning Test—Revised (HVLT-R), Trail Making Test (TMT), Boston Naming Test (BNT), Controlled Oral Word Association Test (COWA), and Wechsler Adult Intelligence Scale (WAIS).

Exclusion criteria

Exclusion criteria: 1 Known neurological disorders that can affect cognitive function (such as dementia, multiple sclerosis, traumatic brain injury), history of central nervous system or bone metastasis cancer, any secondary cancers, use of antihypertensive medications, diagnosis of cardiovascular or cerebrovascular disease; 2 Patients with mental disorders or a history of mental disorders; 3 Regularly engaging in moderate-intensity exercise, cognitive training, or transcranial ultrasound therapy for 3–5 days or more per week; 4 Diseases that may impair participation in exercise; 5 Patients with MRI contraindications who have changed or discontinued endocrine therapy during the study period or within 4 months prior to the study start date.

Design outcomes

Primary

MeasureTime frame
FACT-Cog;

Secondary

MeasureTime frame
hopkins verbal learning test—revised, HVLT-R;Trail making test, TMT;Boston Naming Test,BNT;Controlled Oral Word Association Test, COWA;Wechsler Adult Intelligence Scale, WAIS;

Countries

China

Contacts

Public ContactChen Dan

Shanghai Jing'an District Central Hospital

dan_chendoctor@163.com+86 153 0163 1081

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026