Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage
NCT ID: NCT06375408
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
74 participants
INTERVENTIONAL
2024-03-24
2026-03-24
Brief Summary
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• 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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The intervention group
The intervention group was treated with real transcranial alternating electrical stimulation.
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.
The control group
The control group was treated with sham transcranial alternating electrical stimulation.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KS2022212
Identifier Type: -
Identifier Source: org_study_id
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