Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2025-12-17 @ 5:27 AM
Study NCT ID:
NCT06375408
Status:
None
Last Update Posted:
2024-04-19 00:00:00
First Post:
2024-03-26 00:00:00
Brief Title:
Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital, Beijing
Study Overview
Official Title:
Clinical Study of Transcranial Alternating Current Stimulation in the Prevention of Delirium in Patients With Subarachnoid Hemorrhage
Status:
None
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACS
Brief Summary:
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.
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.
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 SubjectsPatients 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 subjectsThe 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 recorded② Safety indicators the incidence of adverse reactions
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 SubjectsPatients 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 subjectsThe 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 recorded② Safety indicators the incidence of adverse reactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None