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The goal of this clinical trial is to learn about using the latest transcranial alternating current stimulation (tACS) to reduce the incidence of delirium in patients with subarachnoid hemorrhage. The main question it aims to answer is:
• To evaluate the effect of tACS on reducing delirium in patients with subarachnoid hemorrhage.
Participants will treated with real tACS or sham tACS. Researchers will mainly compare the two groups to see if patients' delirium will reduce by using tACS.
Research objectives: To reduce the incidence of delirium in patients with subarachnoid hemorrhage by using the latest transcranial alternating current stimulation.
Research contents:
Research hypothesis: Transcranial alternating current stimulation can improve sleep quality and reduce the incidence of delirium in patients with subarachnoid hemorrhage.
Study design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The intervention group | Experimental | The intervention group was treated with real transcranial alternating electrical stimulation. |
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| The control group | Sham Comparator | The control group was treated with sham transcranial alternating electrical stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real transcranial alternating electrical stimulation | Device | The patients in the intervention group were treated with real tACS produced by Nexalin company. There were 3 treatment sites. According to the international 10-20 EEG system positioning method, one electrode was placed in the prefrontal lobe (Fp1, Fpz, Fp2 area, electrode size was 4.45cm×9.53cm), and the other two electrodes were placed in the left and right mastoid respectively (electrode size was 3.18cm×3.81cm). The treatment parameters were 40min twice daily with an interval of ≥4 hours for a total of 8 sessions over 4 days. tACS procedures were performed by trained and qualified full-time therapeutic nurses. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium | (occurrence of delirium was assessed 3 times a day from the start of the intervention to the day after the intervention ended ) Delirium incidence = Number of people who had experienced delirium within 5 days/total number of people in the intervention or control group. | up to 5days |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality score | The Richard Campell Sleep Questionnaire (RCSQ) consists of five sleep-related items: sleep depth, sleep fall, wake up during sleep, fall back to sleep, and overall sleep quality. A visual analog scale was used to score the patients, with each score ranging from 0 to 100. The average score of 5 sleep-related items was calculated, with 0 to 25 being low-quality sleep and 76 to 100 being high-quality sleep. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Wang, master | Contact | +86-010-83922775 | wangj229@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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The random number table method was used for randomization, and the envelope method was used for randomization. The random serial number was stored in an airtight envelope, an envelope was opened when a patient was admitted.
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| Sham transcranial alternating electrical stimulation | Device | The patients in the control group were treated with sham tACS produced by Nexalin company. The fake tACS does not emit current, so it does not stimulate the cerebral cortex. The appearance, button, electrode, and quality of the fake tACS are exactly the same as those of the real tACS in patients' senses. There were 3 treatment sites. According to the international 10-20 EEG system positioning method, one electrode was placed in the prefrontal lobe (Fp1, Fpz, Fp2 area, electrode size was 4.45cm×9.53cm), and the other two electrodes were placed in the left and right mastoid respectively (electrode size was 3.18cm×3.81cm). The treatment parameters were 40min twice daily with an interval of ≥4 hours for a total of 8 sessions over 4 days. tACS procedures were performed by trained and qualified full-time therapeutic nurses. |
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| up to 5days |
| Anxiety score | Hamilton Anxiety Scale (HAMA), which has 14 items, adopts a 5-level scoring method ranging from 0 to 4 points. The total score is the sum of the scores of 14 items, and the total score is >29 points, which may be severe anxiety. >21 points, there must be obvious anxiety; >14 points, there must be anxiety; More than 7 points, may have anxiety; If the score is less than 7, there is no anxiety symptom. | up to 5days |
| Duration of delirium | The duration of patients' delirium from onset to end. | up to 5days |
| Cognitive function score | mini-mental state examination (MMSE) : There are 30 items in the scale, each item is 1 point, one correct answer will get 1 point, the full score is 30 points, the higher the score, the better the cognitive function: MMSE≥27 is classified as normal, 21-26 as mild dementia, 10-20 as moderate dementia, and < 10 as severe dementia. MMSE is susceptible to the influence of education level, according to the level of education, its boundary standards are illiterate ≤17 points, primary school ≤20 points, secondary school or above education ≤24 points, indicating dementia. | up to 5days |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D003693 | Delirium |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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