NCT06375408

Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage

Clinical Study of Transcranial Alternating Current Stimulation in the Prevention of Delirium in Patients With Subarachnoid Hemorrhage

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DEVICE	Real 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.
DEVICE	Sham transcranial alternating electrical stimulation	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.

Timeline

• Start date: 2024-03-24
• Primary completion: 2026-02-24
• Completion: 2026-03-24
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: China