Clinical trial NCT06375408: Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage
Official title: Clinical Study of Transcranial Alternating Current Stimulation in the Prevention of Delirium in Patients With Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: Subarachnoid Hemorrhage
transcranial alternating current stimulation
delirium
Sleep quality
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Research objectives: To reduce the incidence of delirium in patients with subarachnoid hemorrhage by using the latest transcranial alternating current stimulation.

Research contents:

1. To evaluate the effect of transcranial alternating current stimulation on improving sleep quality in patients with subarachnoid hemorrhage;
2. To evaluate the effect of transcranial alternating current stimulation on reducing delirium in patients with subarachnoid hemorrhage.

Research hypothesis: Transcranial alternating current stimulation can improve sleep quality and reduce the incidence of delirium in patients with subarachnoid hemorrhage.

Study design:

1. double-blind randomized clinical trial
2. Subjects：Patients with subarachnoid hemorrhage admitted to the neurosurgical intensive care unit during the study period.
3. Number of participating centers and names of centers: Single research center, Xuanwu Hospital, Beijing
4. Sample size: The total number of plans was 74, and the total number of study centers was 74.
5. Grouping of subjects：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, a patient was admitted, and an envelope was opened.
6. Intervention measures: ① The control group was treated with sham transcranial electrical stimulation; ② The experimental group was treated with real transcranial electrical stimulation.
7. Outcome measures: ① Efficacy indicators: the incidence and duration of delirium; The scores of Richard Campell sleep questionnaire, Hamilton Anxiety Scale, Mini-Mental State Examination, numerical rating scale for pain and muscle strength were recorded.② Safety indicators: the incidence of adverse reactions.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of delirium
timeFrame: up to 5days
Secondary outcomes:
measure: Sleep quality score
timeFrame: up to 5days
measure: Anxiety score
timeFrame: up to 5days
measure: Duration of delirium
timeFrame: up to 5days
measure: Cognitive function score
timeFrame: up to 5days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
Study officials:
References: