Subarachnoid HemorrhageTACSNCT06375408
Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage
A study testing Real transcranial alternating electrical stimulation in people with Subarachnoid Hemorrhage, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Real transcranial alternating electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2024to 24 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Jun Wang, 18612583695, wangj229@126.com
About this study
Official title: Clinical Study of Transcranial Alternating Current Stimulation in the Prevention of Delirium in Patients With Subarachnoid Hemorrhage
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.
Read the 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:
- To evaluate the effect of transcranial alternating current stimulation on improving sleep quality in patients with subarachnoid hemorrhage;
- 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:
- double-blind randomized clinical trial
- Subjects：Patients with subarachnoid hemorrhage admitted to the neurosurgical intensive care unit during the study period.
- Number of participating centers and names of centers: Single research center, Xuanwu Hospital, Beijing
- Sample size: The total number of plans was 74, and the total number of study centers was 74.
- 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.
- Intervention measures: ① The control group was treated with sham transcranial electrical stimulation; ② The experimental group was treated with real transcranial electrical stimulation.
- 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
- Subarachnoid Hemorrhage
- Being tested
- Real transcranial alternating electrical stimulation, Sham transcranial alternating electrical stimulation
- Keywords
- Subarachnoid Hemorrhage, transcranial alternating current stimulation, delirium, Sleep quality
- Medical subject headings
- Subarachnoid Hemorrhage, Delirium, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real transcranial alternating electrical stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | The intervention group was treated with real transcranial alternating electrical stimulation. Receives: Device: Real transcranial alternating electrical stimulation |
| The control group | Sham comparator | The control group was treated with sham transcranial alternating electrical stimulation. Receives: Device: Sham transcranial alternating electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5days
Secondary outcomes (4)
Sleep quality score
The Richard Campell Sleep Questionnaire (RCSQ) consists of five sleep-related items: sleep depth, sleep fall, wake up during sleep, fall back to sleep, and overall sleep quality. A visual analog scale was used to score the patients, with each score ranging from 0 to 100. The average score of 5 sleep-related items was calculated, with 0 to 25 being low-quality sleep and 76 to 100 being high-quality sleep.
Measured: up to 5days
Anxiety score
Hamilton Anxiety Scale (HAMA), which has 14 items, adopts a 5-level scoring method ranging from 0 to 4 points. The total score is the sum of the scores of 14 items, and the total score is >29 points, which may be severe anxiety. >21 points, there must be obvious anxiety; >14 points, there must be anxiety; More than 7 points, may have anxiety; If the score is less than 7, there is no anxiety symptom.
Measured: up to 5days
Duration of delirium
The duration of patients' delirium from onset to end.
Measured: up to 5days
Cognitive function score
mini-mental state examination (MMSE) : There are 30 items in the scale, each item is 1 point, one correct answer will get 1 point, the full score is 30 points, the higher the score, the better the cognitive function: MMSE≥27 is classified as normal, 21-26 as mild dementia, 10-20 as moderate dementia, and < 10 as severe dementia. MMSE is susceptible to the influence of education level, according to the level of education, its boundary standards are illiterate ≤17 points, primary school ≤20 points, secondary school or above education ≤24 points, indicating dementia.
Measured: up to 5days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start24 Mar 2024
- Primary completion24 Feb 2026 (estimated)
- Study completion24 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375408
- Sponsor's protocol ID
- KS2022212
- Acronym
- TACS
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Transcranial Alternating Current Stimulation in the Prevention of Delirium in Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06375408
- Acronym / sponsor ID
- TACS / KS2022212
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage, transcranial alternating current stimulation, delirium, Sleep quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 24 Feb 2026 (estimated)
- Study completion
- 24 Mar 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To evaluate the effect of transcranial alternating current stimulation on improving sleep quality in patients with subarachnoid hemorrhage;
- 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:
- double-blind randomized clinical trial
- Subjects：Patients with subarachnoid hemorrhage admitted to the neurosurgical intensive care unit during the study period.
- Number of participating centers and names of centers: Single research center, Xuanwu Hospital, Beijing
- Sample size: The total number of plans was 74, and the total number of study centers was 74.
- 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.
- Intervention measures: ① The control group was treated with sham transcranial electrical stimulation; ② The experimental group was treated with real transcranial electrical stimulation.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Device: Real transcranial alternating electrical stimulationThe intervention group was treated with real transcranial alternating electrical stimulation. |
| The control group | Sham comparator | Device: Sham transcranial alternating electrical stimulationThe control group was treated with sham transcranial alternating electrical stimulation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real transcranial alternating electrical stimulationThe 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 | The intervention group |
| Sham transcranial alternating electrical stimulationThe 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. | Device | The control group |
Primary outcome
Incidence of delirium
Time frame: up to 5days
(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.
4 secondary outcomes
Sleep quality score
Time frame: up to 5days
Anxiety score
Time frame: up to 5days
Duration of delirium
Time frame: up to 5days
Cognitive function score
Time frame: up to 5days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real transcranial alternating electrical stimulation in people with Subarachnoid Hemorrhage, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Wang, master (+86-010-83922775, wangj229@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: up to 5days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.