Post-Stroke Cognitive Impairment
Conditions
Interventions
The taVNS treatment group:Using an electronic acupuncture device, attach the ear clip electrode to the vagus nerve ear reflex area (the concha) on the left ear of the patient. Set the stimulation para
frequency 5Hz, pulse width 200µs, adjust the current intensity to the maximum level that the patient can tolerate (with no obvious pain or discomfort as the criterion). 20 minutes per session per day,
The sham stimulation control group:On the basis of conventional rehabilitation training, sham-taVNS treatment was administered using non-contact electrodes, which displayed current readings on the dev
Synchronous treatment group:On the basis of conventional rehabilitation training, taVNS and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) were implemented simultaneously for tr
Sequential treatment group (central first, then peripheral):On the basis of conventional rehabilitation training, sequential treatment with HF-rTMS and taVNS was adopted.
First, HF-rTMS treatment was
After the HF-rTMS treatment, taVNS treatment was immediately initiated, with the operation and parameters being the same as those of the taVNS group, and each treatment lasted for 20 minutes
It was performed once a day (with the two treatments completed consecutively), 5 times a week, for a total of 3 weeks.
Sponsors
The Rehabilitation Medicine Department of Huai'an Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All the selected stroke patients met the diagnostic criteria of the Vascular Cognitive Impairment Committee of the Chinese Stroke Association's "Expert Consensus on Management of Post-stroke Cognitive Impairment 2021". They were diagnosed with cerebral infarction through cranial CT or MRI examination. They also met the diagnostic points of post-stroke cognitive impairment (PSCI) as stipulated in this consensus, that is, cognitive function decline occurred after stroke, and the score of the Mini-Mental State Examination (MMSE) was in line with the cultural level classification standards (please refer to item 5 of this paragraph). 2. Age 18-70 years old; 3. First onset, with a disease course of more than 3 months but less than 6 months; 4.Able to cooperate with the completion of treatment programs and scale scoring (including aphasia patients); 5.MMSE assessment criteria: used to quantify the degree of cognitive impairment, classified by cultural level, those with illiteracy (no education received) have a score 6 years) have a score <= 24 points; 6.Before the occurrence of stroke, there was no history of cognitive impairment or mental illness; 7. Agree to participate in this trial, sign the informed consent form, and have complete data.
Exclusion criteria
Exclusion criteria: 1.Those with a history of head trauma (Glasgow Coma Scale score <= 12) or who have undergone head surgery; 2.Those with neurodegenerative diseases or episodic disorders such as Parkinson's disease, epilepsy (with a seizure history within the past 1 year), Alzheimer's disease, etc. that may independently cause cognitive impairment; 3. Those with implanted electronic medical devices (such as cardiac pacemakers, deep brain stimulators), brain metal foreign bodies (non-titanium alloy materials), or who have undergone ventriculoperitoneal shunt surgery; 4.Those wearing an artificial cochlea, having second-degree or higher atrioventricular conduction block, or experiencing acute asthma attacks; 5.Those whose standard parameters (stimulation intensity 80%-120% of the resting motor threshold) for repetitive transcranial magnetic stimulation on the motor area of the healthy or affected side fail to elicit motor evoked potentials (MEP); 6.Those who already have cognitive decline before a stroke or have been diagnosed with mental disorders (such as schizophrenia, severe depression) before; 7.Those with severe organ dysfunction (such as New York Heart Function Classification Grade IV, chronic renal failure uremic stage, liver cirrhosis decompensation stage, etc.) or advanced malignant tumors (expected survival period < 6 months); 8. Those with severe sensory disorders (such as complete loss of deep sensation in the affected limb), aphasia (complete motor aphasia or mixed aphasia), or extremely low cognitive level (MMSE score < 10), unable to understand instructions and cooperate to complete treatment and assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination,MMSE;Montreal Cognitive Assessment;Loewenstein Occupational Therapy Cognitive Assessment;Resting-state functional magnetic resonance imaging; | — |
Countries
China
Contacts
Public ContactLi Xuejing
The Second People's Hospital of Huai'an City
Outcome results
None listed