An interventional study of Real transcranial alternating electrical stimulation and Sham transcranial alternating electrical stimulation in Subarachnoid Hemorrhage, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Prevention
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:
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:
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 74 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention group was treated with real transcranial alternating electrical stimulation.
Device: Real transcranial alternating electrical stimulation
The control group was treated with sham transcranial alternating electrical stimulation.
Device: Sham transcranial alternating electrical stimulation
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.
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.
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.
Time frame: up to 5days
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.
Time frame: 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.
Time frame: up to 5days
Duration of delirium
The duration of patients' delirium from onset to end.
Time frame: 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.
Time frame: up to 5days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xuanwu Hospital, Beijing