Using electrical stimulation to prevent delirium in patients with brain hemorrhage

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

This study is testing if a type of electrical stimulation can help prevent delirium and improve sleep in patients who have had a brain hemorrhage.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06375408 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of transcranial alternating current stimulation (tACS) in reducing the incidence of delirium among patients who have experienced a subarachnoid hemorrhage. Participants will be randomly assigned to receive either real tACS or a sham treatment, allowing researchers to compare the outcomes between the two groups. The study will also assess the impact of tACS on improving sleep quality in these patients. The trial is designed as a double-blind randomized clinical trial conducted at Xuanwu Hospital in Beijing.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have undergone surgical treatment for subarachnoid hemorrhage and are classified as Hunt & Hess grade I-III.

Not a fit: Patients who are already experiencing delirium at the time of enrollment or have serious mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the occurrence of delirium in patients recovering from subarachnoid hemorrhage.

How similar studies have performed: While the use of tACS is a relatively novel approach, similar studies have shown promise in using non-invasive brain stimulation techniques for various neurological conditions.

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.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital Capital Medical University — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Jun Wang, master

Conditions: Subarachnoid Hemorrhage, transcranial alternating current stimulation, delirium, Sleep quality