Subarachnoid Hemorrhage Clinical Trial
— TACSOfficial title:
Clinical Study of Transcranial Alternating Current Stimulation in the Prevention of Delirium in Patients With Subarachnoid Hemorrhage
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.
Status | Recruiting |
Enrollment | 74 |
Est. completion date | March 24, 2026 |
Est. primary completion date | February 24, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Subarachnoid hemorrhage was consistent with the Chinese Guidelines for the Diagnosis and Treatment of Subarachnoid Hemorrhage 2015; - Patients after completion of surgical treatment; - over 18 years of age; - Hunt & Hess grade I-III; - No major organ failure; - The patient has no speech or hearing impairment; - Informed consent of patients and their families, signed informed consent. Exclusion Criteria: - Those who have delirium at the time of enrollment; - had substance abuse/dependence within 6 months before enrollment; - had suffered from other mental illness within 6 months before enrollment; - Suffering from serious or unstable organic diseases; - Pregnant or lactating women and those planning to become pregnant in the near future; - Damaged skin integrity at the electrode placement site, allergic to electrode gels or adhesives. - with an implanted electronic stimulator; - Patients who had received other noninvasive neuromodulation therapy within 1 month before enrollment; - Participants in any other clinical trial within 1 month prior to baseline; - There are circumstances in which the researcher considers it inappropriate to participate in this study. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | up to 5days | |
Secondary | 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 | |
Secondary | Duration of delirium | The duration of patients' delirium from onset to end. | up to 5days | |
Secondary | 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 |
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