Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage

NCT06375408 | Recruiting

• 1 other identifier: KS2022212
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid Hemorrhage; transcranial alternating current stimulation; delirium; Sleep quality

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 5days

Secondary Outcomes (4)

• Sleep quality score

  up to 5days

• Anxiety score

  up to 5days

• Duration of delirium

  up to 5days

• Cognitive function score

  up to 5days

Study Arms (2)

The intervention group

EXPERIMENTAL

The intervention group was treated with real transcranial alternating electrical stimulation.

Device: Real transcranial alternating electrical stimulation

The control group

SHAM COMPARATOR

The control group was treated with sham transcranial alternating electrical stimulation.

Device: Sham transcranial alternating electrical stimulation

Interventions

Real transcranial alternating electrical stimulation DEVICE

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 intervention group

Sham transcranial alternating electrical stimulation DEVICE

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.

The control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Delirium; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Central Study Contacts

Jun Wang, master

CONTACT

+86-010-83922775; wangj229@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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, an envelope was opened when a patient was admitted.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 19, 2024
• Study Start: March 24, 2024
• Primary Completion: February 24, 2026
• Study Completion: March 24, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-03

Locations

CN (1)