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Cerebral AneurysmASSETNCT05413460

Acupoint Stimulation and Cranial Endovascular Treatment

A study testing transcutaneous electrical acupoint stimulation in people with Cerebral Aneurysm, run by Zhihong LU at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (TEAS) and group control (no intervention). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Aneurysm
What is being tested?
transcutaneous electrical acupoint stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteChina
Study dates
26 Jul 2022to 30 Jun 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age ≥18 years
  • patients scheduled for cranial endovascular treatment

Who cannot join

  • American Society of Anesthesiologists class Ⅲ or higher
  • Hunt-Hess class Ⅲ or higher
  • body mass index (BMI) < 18 kg/㎡ or > 30kg/㎡
  • large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm
  • posterior circulation infarction
  • recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping
Show all 13Show fewer
  • severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure
  • injury or infection of the skin around the acupoint area
  • participate in other clinical researchers within 3 months
  • history of neurological or psychiatric diseases
  • patients with implanted electrophysiological device
  • use of sedative or analgesics before surgery
  • patients with difficulty in communication

Trial locations and contacts

1 site in 1 country.

Zhihong Lu contact

+8613891975018

deerlu23@163.com

Minjuan Zhang contact

8684775343

947391349@qq.com

China1 site, 1 recruiting

  • Xijing hospital, Fourth military medical university

    Xi'an, Shaanxi, 710032

    Zhihong Lu, 13891975018, deerlu23@163.com

    Recruiting

Other trials in China

About this study

Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Cranial Endovascular Treatment

In this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (TEAS) and group control (no intervention). The postoperative outcomes including NIHSS (National Institute of Health stroke scale) score, morbidity and mortality will be evaluated during hospital stay and by one year after surgery.

Being tested
transcutaneous electrical acupoint stimulation
Keywords
transcutaneous electrical acupoint stimulation, endovascular treatment
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcutaneous electrical acupoint stimulationDevice

    Also called TEAS

    Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.

Study groups in NCT05413460
Study groupRoleWhat they receive
transcutaneous electrical acupoint stimulationExperimentalElectrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Receives: Device: transcutaneous electrical acupoint stimulation
ControlNo interventionElectrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients with major in-hospital postoperative complications

    major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma

    Measured: from end of surgery to discharge from hospital, in an average of 7 days

Secondary outcomes (15)

  1. mortality by 30 days after surgery

    Measured: from end of surgery to 30 days after surgery, in a total of 30 days

  2. mortality by 3 months after surgery

    Measured: from end of surgery to 3 months after surgery, in a total of 3 months

  3. number of patients with major postoperative complications by 3 months after surgery

    major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma

    Measured: from end of surgery to 3 months after surgery, in a total of 3 months

  4. mortality by 6 months after surgery

    Measured: from end of surgery to 6 months after surgery, in a total of 6 months

  5. number of patients with major postoperative complications by 6 months after surgery

    major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma

    Measured: from end of surgery to 6 months after surgery, in a total of 6 months

  6. duration of postoperative in-hospital stay

    Measured: from end of surgery to discharge from hospital, in an average of 7 days

  7. serum interleukin-6 level at the end of the surgery

    Measured: at end of the surgery

  8. serum tumor necrosis factor-α level at the end of the surgery

    Measured: at end of the surgery

  9. episodes of hypotension during surgery

    hypotension is defined as mean arterial pressure decreased by more than 20% of the baseline and persisting more than 1 minute

    Measured: from start of surgery to end of surgery, in an average of 2 hours

  10. Score of Mini-mental State Examination at 1 day after surgery

    A Mini-Mental State Examination (MMSE) is a set of 30 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE is with a maximal score of 30. A higher score means better cognitive function.

    Measured: at 24h after the end of surgery

  11. Score of Mini-mental State Examination at 3 days after surgery

    A Mini-Mental State Examination (MMSE) is a set of 30 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE is with a maximal score of 30. A higher score means better cognitive function.

    Measured: at 72h after the end of surgery

  12. visual analog scale of pain at 1 day after surgery

    visual analogue scale is a scale of 10cm, 0 is for no pain, 10 is for pain that can not be tolerated. The participant is asked to mark the scale of their pain

    Measured: at 24h after the end of surgery

  13. visual analog scale of pain at 3 days after surgery

    visual analogue scale is a scale of 10cm, 0 is for no pain, 10 is for pain that can not be tolerated. The participant is asked to mark the scale of their pain

    Measured: at 72h after the end of surgery

  14. Quality of recovery score at 3 days after surgery

    Quality of recovery-40 is a questionnaire consisted of 40 questions about the recovery of the patient. Higher score means better recovery.

    Measured: at 72h after the end of surgery

  15. Rankin's score at 3 days after surgery

    Rankin's score consists of class of 6 levels and is used for evaluation of neurologic function. Higher score means worse outcome.

    Measured: at 72h after the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start26 Jul 2022
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

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
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413460
Sponsor's protocol ID
XJH-A-20200730
Acronym
ASSET
Status last verified
Dec 2022
First submitted
25 May 2022
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dhillon PS, Butt W, Podlasek A, McConachie N, Lenthall R, Nair S, Malik L, Hewson DW, Bhogal P, Makalanda HLD, James MA, Dineen RA, England TJ. Association between anesthesia modality and clinical outcomes following endovascular stroke treatment in the extended time window. J Neurointerv Surg. 2023 May;15(5):478-482. doi: 10.1136/neurintsurg-2022-018846. Epub 2022 Apr 21.

    PubMed 35450928

  • Campbell D, Deng C, McBryde F, Billing R, Diprose WK, Short TG, Frampton C, Brew S, Barber PA; MASTERSTROKE Study Group. Protocol for the MAnagement of Systolic blood pressure during Thrombectomy by Endovascular Route for acute ischemic STROKE randomized clinical trial: The MASTERSTROKE trial. Int J Stroke. 2022 Aug;17(7):810-814. doi: 10.1177/17474930211059029. Epub 2021 Nov 22.

    PubMed 34806930

  • Samuels N, van de Graaf RA, van den Berg CAL, Uniken Venema SM, Bala K, van Doormaal PJ, van der Steen W, Witvoet E, Boiten J, den Hertog H, Schonewille WJ, Hofmeijer J, Schreuder F, Schreuder TAHCML, van der Worp HB, Roos YBWEM, Majoie CBLM, Burke JF, van Es ACGM, van der Lugt A, Roozenbeek B, Lingsma HF, Dippel DWJ; MR CLEAN Registry Investigators. Blood Pressure in the First 6 Hours Following Endovascular Treatment for Ischemic Stroke Is Associated With Outcome. Stroke. 2021 Nov;52(11):3514-3522. doi: 10.1161/STROKEAHA.120.033657. Epub 2021 Sep 20.

    PubMed 34538090

  • Qu KL, Fu JW, He T, Zhang MJ, Huo Y, Lu ZH. Effect of transcutaneous electrical acupoint stimulation on major complications after cerebral endovascular procedures (ASSET): study protocol for a randomized controlled trial. Int J Surg Protoc. 2026 Apr 8;30(2):14-19. doi: 10.1097/SP9.0000000000000065. eCollection 2026 Jun.

    PubMed 42164180

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous electrical acupoint stimulation in people with Cerebral Aneurysm, run by Zhihong LU 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 2 inclusion and 13 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 6 Dec 2022. 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. 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 Zhihong Lu (+8613891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients with major in-hospital postoperative complications (time frame: from end of surgery to discharge from hospital, in an average of 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413460, which also lists 4 linked publications.

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 6 Dec 2022.

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