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Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage

NCT06375408 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

  • Subarachnoid Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-24
Primary Completion
2026-02-24
Completion
2026-03-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375408 on ClinicalTrials.gov