Postoperative Cognitive DysfunctionTEASNCT05482477
Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor
A study testing Transcutaneous acupoint electrical stimulation in people with Postoperative Cognitive Dysfunction, run by Subei People's Hospital of Jiangsu Province at 1 site in China.
Trial summary
Postoperative cognitive dysfunction(POCD). is a central nervous system complication in cancer patients with a 8.9-46.1% incidence. It is mainly manifested as impaired memory, descending information handling ability and decline or damage of attention, perception, abstract thinking, executive, language, and body… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Transcutaneous acupoint electrical stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 60 years or older.
- Patients diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia in Subei People's Hospital of Jiangsu province.
- Patients willing and able to give informed consent and comply with this study protocol.
- American Society of Anesthesiology (ASA) classification I～III. ⑤ Preoperative Tilburg frailty scale score is less than 5 points. ⑥ Preoperative D-dimer was normal.
Who cannot join
- Preoperative cognitive dysfunction or history of cognitive dysfunction, dementia, and delirium.
- History of severe depression, schizophrenia, or other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past.
- Patients with severe hearing or visual impairment without assistive tools.
- Patients who have difficulty in communicating.
- Male patients average daily pure alcohol intake ≥ 61 g or female patients average daily pure alcohol intake ≥ 41 g.
- Patients received surgical treatment within 3 months or preoperative hospitalized over 3 months.
Show all 13Show fewer
- Patients with severe heart, liver, or renal failure.
- ⑧ Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 min during the operation.
- ⑨ Patients admitted to ICU after operation.
- ⑩ Patients who quit or died due to noncooperation or sudden situation.
- ⑪ Patients who already participate in other clinical studies which may influence this study.
- ⑫ Patients who underwent emergency surgery.
- ⑬ Patients who had a history of acupuncture treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Liqun - Shi, -, 0514-87373694, sbyy112012@163.com
About this study
Official title: Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor：a Protocol of Randomised Controlled Trial
Postoperative cognitive dysfunction(POCD). is a central nervous system complication in cancer patients with a 8.9-46.1% incidence. It is mainly manifested as impaired memory, descending information handling ability and decline or damage of attention, perception, abstract thinking, executive, language, and body movement. However, it is difficult to identify and it can last for months or years or even become a dementia state, which can severely affect patients' postoperative recovery, prolong the hospitalization time, reduce the quality of life, increase the mortality and the consumption of family and social medical resources, and intensifies the national economic and social burden.
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Also, studies have shown that TEAS treatment may improve the cognitive function of geriatric patients. Most studies have shown that TEAS treatment 10~30 minutes before operation or from entering the operating room to the end of operation can reduce the incidence of POCD in elderly patients. Some studies showed that preoperative combined with postoperative or simple postoperative TEAS treatment can significantly improve patients' postoperative cognitive function. Our previous research showed that perioperative TEAS treatment can reduce the postoperative inflammatory response and increased the postoperative cognitive function score and decrease the incidence of POCD in geriatric patients with gastrointestinal tumor. Moreover, studies showed that long-term electroacupuncture treatment is easy to cause "tolerance effect', leading to the activation of the negative feedback mechanism of the body, and reduction of the number of receptors, and the weakening of the treatment effect. So, what is the best time period for TEAS to improve POCD and reduce the use of resources? Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.
Read the detailed description
Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Transcutaneous acupoint electrical stimulation
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous acupoint electrical stimulationOther
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
| Study group | Role | What they receive |
|---|---|---|
| preoperative TEAS group | Experimental | Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before anesthesia. Receives: Other: Transcutaneous acupoint electrical stimulation |
| Intraoperative TEAS group | Experimental | Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 30 min before anesthesia to the end of surgery Receives: Other: Transcutaneous acupoint electrical stimulation |
| Postoperative TEAS group | Experimental | Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, once a day, 30 minutes each time for 7 consecutive days after operation Receives: Other: Transcutaneous acupoint electrical stimulation |
| Pre-and post-operative TEAS group | Experimental | Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 1 day before operation to 7 days after operation, once a day, 30 minutes each time. Receives: Other: Transcutaneous acupoint electrical stimulation |
| Perioperative TEAS group | Experimental | Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before the induction of anesthesia to the end of the surgery, 1 day before operation, and on the 1st, 2nd and 3rd days after surgery, 30 min once a day. Receives: Other: Transcutaneous acupoint electrical stimulation |
| Sham TEAS group | Sham comparator | the electrodes were placed at the same time as the perioperative TEAS group, but the electronic stimulation was not applied and they were told that the TEAS treatment have no feeling Receives: Other: Transcutaneous acupoint electrical stimulation |
| Control group | No intervention | receive standardised perioperative management such as preoperative health education, optimize anaesthesia scheme, intraoperative heat preservation, and reduce surgical trauma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination(MMSE)
Assess the cognitive function of the patient. The MMSE is a 30 points questionnaire used to measure orientation (time and place), memory (immediate and short term), attention, calculation, and language (naming, repetition, listening, reading, and writing) . Higher score means better cognitive function.
Measured: From preoperative to 3 days after operation
Auditory Verbal Learning Test-HuaShan version(AVLT-H)
Assess the cognitive function of the patient. AVLT-H was used to evaluate the memory of the subjects.The subjects learned and recalled 12 words and repeated themself three times. After the nonverbal test interval of about 5min and 20min, the fourth (short delayed recall) and fifth (long delayed recall) repeat will be recorded respectively. The sixth recall was reconfirmation, that is, the data collectors read 24 words, and the subjects answered whether they had learned them. According to the knowledge level and cooperation degree of local elderly subjects, the fourth repeat will be recorded and a correct word will get 1 point.
Measured: From preoperative to 3 days after operation
Digital Symbol Coding(DSC)
Assess the cognitive function of the patient. DSC was used to evaluate the executive function of the subjects. For the test, the subjects need to fill in the numbers corresponding to the symbols within 90s. A correct number will get 1 point, up to 90 points.
Measured: From preoperative to 3 days after operation
Verbal Fluency Test(VFT)
Assess the cognitive function of the patient. VFT was used to evaluate the language ability of the subjects. The subjects should say as many names of animals, fruits and vegetables as possible within 1 minute. A correct object will get 1 point, no point will be given if repeated.
Measured: From preoperative to 3 days after operation
Clock Drawing Task(CDT)
Assess the cognitive function of the patient. CDT was used to evaluate the visual spatial structure ability of the subjects. The subjects need to draw the dial of the clock on paper and write the numbers in the correct position. Scoring method: ① Draw a closed circular outline, 1 point. ②The number display and sequence in the dial are correct, 2 points. ③The position of the hour and minute hand is correct, 1 point. To reduce the learning effect, the test time preoperative and postoperative in this study is drawn at 08:10 and 07:50 respectively.
Measured: From preoperative to 3 days after operation
Secondary outcomes (12)
Interleukin-6(IL-6)
Evaluate patients' postoperative inflammatory status. IL-6 is a pro-inflammatory cytokine which can mediate inflammatory and immune responses in the CNS.
Measured: Baseline and on the 3rd day after the operation
S100 calcium proteinβ(S100β)
Evaluate patients' postoperative inflammatory status. S100β is a biomarker which existed in the cell of peripheral and central nervous system(CNS) and it may participate in the mechanism of cognitive impairment.
Measured: Baseline and on the 3rd day after the operation
insulin-like growth factor-1( IGF-1 )
Evaluate patients' postoperative inflammatory status. As one of the neurotrophic factors, IGF-1 has been proved to have neuroprotective and neuroproliferative effects and it may delay the degeneration of dopaminergic neurons, protect dopaminergic neurons and promote nerve regeneration through a variety of ways, including inhibiting inflammatory reaction. IGF-1 plays an important role in the survival and differentiation of neurons, and is related to a variety of neurodegenerative diseases. Studies showed that the level of serum IGF-1 in patients with Parkinson's disease(PD) is related to cognitive dysfunction, and serum IGF-1 may be a biomarker of cognitive dysfunction in patients with PD.
Measured: Baseline and on the 3rd day after the operation
C-reactive protein(CRP)
Evaluate patients' postoperative inflammatory status. CRP is a non-specific biomarker inflammation which has been proved to accelerate the development of neurodegenerative disorders by activating microglia, increasing levels of proinflammatory cytokines, and activating the complement cascade.
Measured: Baseline and on the 3rd day after the operation
Numerical pain score(NRS)
Evaluate the postoperative recovery of patients. On the scale of the 10 point system, the self rating is based on the degree, which is divided into 1-10 levels. According to the corresponding numbers, the pain can be divided into different degrees, that is, level 0 means no pain, level 1-3 means mild pain, level 4-6 means moderate pain, and level 7-10 means severe pain.
Measured: on the third day after operation
Score of Branden pressure ulcer risk assessment scale(Branden)
Branden is divided into six dimensions: perception, humidity, activity mode, activity ability, nutrition, friction and shear force. The friction and shear force are rated at Level 3, and the rest are rated at level 4, with a score range of 6-23 points. The higher the score, the smaller the risk of pressure ulcer occurrence, with 15-18 points for mild risk, 13-14 points for moderate risk, 10-12 points for high risk, and ≤ 9 points for serious risk.
Measured: The seventh day after operation
Score of Barthel index (BI)
BI is a tool widely used in clinic to evaluate patients'activities of daily living(ADL). It includes 10 items, including diet, bed and wheelchair transfer, personal hygiene, toileting, bathing, walking, going up and down stairs, dressing, defecation control and urination control, with a total score of 100 points. If the score is in the range of 0 ~ 40 points, it belongs to severe ADL deficiency; if it is in the range of 41 ~ 60 points, it belongs to moderate ADL deficiency; if it is in the range of 61 ~ 100 points, it belongs to mild ADL deficiency. The BI scale can be evaluated by asking patients or their families, which is simple, fast and highly reliability.
Measured: The seventh day after operation
Telephone Interview for Cognitive Status-Modified(TICS-m)
Assess the cognitive function of the patient. TICS-m is modified from the earliest version of TICS which is modeled on MMSE. Gallo and Breitiner revised the original version, adding tests such as delayed memory of words and five times of phone tapping, and expanded it to 21 items, with a total score of 50 points. It can be divided into three parts: memory (20 points), orientation (13 points), language and attention (17 points). The higher the score, the better the condition of the project. <28 points is defined as dementia, 28~32 points is defined as mild cognitive impairment(MCI). More over the TICS-m has been proved to have good reliability and validity in the Chinese population.
Measured: 1, 3, 6 months after operation.
Postoperative exhaust time
Record the first anal exhaust time after operation
Measured: The second day after operation
Postoperative defecation time
Record the first defecation time after operation
Measured: The second day after operation
Postoperative eating time
Record the first eating time after operation
Measured: The second day after operation
The time of get out of bed for the first time after operation
Record the time of get out of bed for the first time after operation
Measured: The second day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Subei People's Hospital of Jiangsu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijuan Xi, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482477
- Sponsor's protocol ID
- Lujuan Xi
- Acronym
- TEAS
- Status last verified
- Sep 2024
- First submitted
- 24 Jul 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin X, Chen Y, Zhang P, Chen G, Zhou Y, Yu X. The potential mechanism of postoperative cognitive dysfunction in older people. Exp Gerontol. 2020 Feb;130:110791. doi: 10.1016/j.exger.2019.110791. Epub 2019 Nov 23.
PubMed 31765741Deiner S, Liu X, Lin HM, Jacoby R, Kim J, Baxter MG, Sieber F, Boockvar K, Sano M. Does Postoperative Cognitive Decline Result in New Disability After Surgery? Ann Surg. 2021 Dec 1;274(6):e1108-e1114. doi: 10.1097/SLA.0000000000003764.
PubMed 32149824Liu J, Huang K, Zhu B, Zhou B, Ahmad Harb AK, Liu L, Wu X. Neuropsychological Tests in Post-operative Cognitive Dysfunction: Methods and Applications. Front Psychol. 2021 Jun 4;12:684307. doi: 10.3389/fpsyg.2021.684307. eCollection 2021.
PubMed 34149572Xi L, Fang F, Yuan H, Wang D. Transcutaneous electrical acupoint stimulation for postoperative cognitive dysfunction in geriatric patients with gastrointestinal tumor: a randomized controlled trial. Trials. 2021 Aug 23;22(1):563. doi: 10.1186/s13063-021-05534-9.
PubMed 34425851Ricci M, Graef S, Blundo C, Miller LA. Using the Rey Auditory Verbal Learning Test (RAVLT) to differentiate alzheimer's dementia and behavioural variant fronto-temporal dementia. Clin Neuropsychol. 2012;26(6):926-41. doi: 10.1080/13854046.2012.704073. Epub 2012 Jul 18.
PubMed 22809061Wessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.
PubMed 33049114Bertola L, Mota NB, Copelli M, Rivero T, Diniz BS, Romano-Silva MA, Ribeiro S, Malloy-Diniz LF. Graph analysis of verbal fluency test discriminate between patients with Alzheimer's disease, mild cognitive impairment and normal elderly controls. Front Aging Neurosci. 2014 Jul 29;6:185. doi: 10.3389/fnagi.2014.00185. eCollection 2014.
PubMed 25120480Leissing-Desprez C, Thomas E, Segaux L, Broussier A, Oubaya N, Marie-Nelly N, Laurent M, Cleret de Langavant L, Fromentin I, David JP, Bastuji-Garin S. Understated Cognitive Impairment Assessed with the Clock-Drawing Test in Community-Dwelling Individuals Aged >/=50 Years. J Am Med Dir Assoc. 2020 Nov;21(11):1658-1664. doi: 10.1016/j.jamda.2020.03.016. Epub 2020 May 6.
PubMed 32387111Yin W, Fang F, Zhang Y, Xi L. Timing of transcutaneous acupoint electrical stimulation for postoperative recovery in geriatric patients with gastrointestinal tumors: study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Mar 5;12:1497647. doi: 10.3389/fmed.2025.1497647. eCollection 2025.
PubMed 40109717
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor：a Protocol of Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05482477
- Acronym / sponsor ID
- TEAS / Lujuan Xi
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Subei People's Hospital of Jiangsu ProvinceUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Aug 2022 (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.
Postoperative cognitive dysfunction(POCD). is a central nervous system complication in cancer patients with a 8.9-46.1% incidence. It is mainly manifested as impaired memory, descending information handling ability and decline or damage of attention, perception, abstract thinking, executive, language, and body movement. However, it is difficult to identify and it can last for months or years or even become a dementia state, which can severely affect patients' postoperative recovery, prolong the hospitalization time, reduce the quality of life, increase the mortality and the consumption of family and social medical resources, and intensifies the national economic and social burden.
Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery.
Also, studies have shown that TEAS treatment may improve the cognitive function of geriatric patients. Most studies have shown that TEAS treatment 10~30 minutes before operation or from entering the operating room to the end of operation can reduce the incidence of POCD in elderly patients. Some studies showed that preoperative combined with postoperative or simple postoperative TEAS treatment can significantly improve patients' postoperative cognitive function. Our previous research showed that perioperative TEAS treatment can reduce the postoperative inflammatory response and increased the postoperative cognitive function score and decrease the incidence of POCD in geriatric patients with gastrointestinal tumor. Moreover, studies showed that long-term electroacupuncture treatment is easy to cause "tolerance effect', leading to the activation of the negative feedback mechanism of the body, and reduction of the number of receptors, and the weakening of the treatment effect. So, what is the best time period for TEAS to improve POCD and reduce the use of resources? Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.
Detailed description
Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| preoperative TEAS group | Experimental | Other: Transcutaneous acupoint electrical stimulationReceive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before anesthesia. |
| Intraoperative TEAS group | Experimental | Other: Transcutaneous acupoint electrical stimulationReceive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 30 min before anesthesia to the end of surgery |
| Postoperative TEAS group | Experimental | Other: Transcutaneous acupoint electrical stimulationReceive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, once a day, 30 minutes each time for 7 consecutive days after operation |
| Pre-and post-operative TEAS group | Experimental | Other: Transcutaneous acupoint electrical stimulationReceive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 1 day before operation to 7 days after operation, once a day, 30 minutes each time. |
| Perioperative TEAS group | Experimental | Other: Transcutaneous acupoint electrical stimulationReceive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before the induction of anesthesia to the end of the surgery, 1 day before operation, and on the 1st, 2nd and 3rd days after surgery, 30 min once a day. |
| Sham TEAS group | Sham comparator | Other: Transcutaneous acupoint electrical stimulationthe electrodes were placed at the same time as the perioperative TEAS group, but the electronic stimulation was not applied and they were told that the TEAS treatment have no feeling |
| Control group | No intervention | –receive standardised perioperative management such as preoperative health education, optimize anaesthesia scheme, intraoperative heat preservation, and reduce surgical trauma. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 60 years or older.
Key exclusion criteria (13 listed)
- Preoperative cognitive dysfunction or history of cognitive dysfunction, dementia, and delirium.
- ⑧ Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 min during the operation.
- ⑨ Patients admitted to ICU after operation.
- ⑩ Patients who quit or died due to noncooperation or sudden situation.
- ⑪ Patients who already participate in other clinical studies which may influence this study.
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 |
|---|---|---|
| Transcutaneous acupoint electrical stimulationTranscutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery. | Other | Intraoperative TEAS group, Perioperative TEAS group, Postoperative TEAS group, Pre-and post-operative TEAS group, Sham TEAS group, preoperative TEAS group |
Primary outcome
Mini-Mental State Examination(MMSE)
Time frame: From preoperative to 3 days after operation
Assess the cognitive function of the patient. The MMSE is a 30 points questionnaire used to measure orientation (time and place), memory (immediate and short term), attention, calculation, and language (naming, repetition, listening, reading, and writing) . Higher score means better cognitive function.
Auditory Verbal Learning Test-HuaShan version(AVLT-H)
Time frame: From preoperative to 3 days after operation
Assess the cognitive function of the patient. AVLT-H was used to evaluate the memory of the subjects.The subjects learned and recalled 12 words and repeated themself three times. After the nonverbal test interval of about 5min and 20min, the fourth (short delayed recall) and fifth (long delayed recall) repeat will be recorded respectively. The sixth recall was reconfirmation, that is, the data collectors read 24 words, and the subjects answered whether they had learned them. According to the knowledge level and cooperation degree of local elderly subjects, the fourth repeat will be recorded and a correct word will get 1 point.
Digital Symbol Coding(DSC)
Time frame: From preoperative to 3 days after operation
Assess the cognitive function of the patient. DSC was used to evaluate the executive function of the subjects. For the test, the subjects need to fill in the numbers corresponding to the symbols within 90s. A correct number will get 1 point, up to 90 points.
Verbal Fluency Test(VFT)
Time frame: From preoperative to 3 days after operation
Assess the cognitive function of the patient. VFT was used to evaluate the language ability of the subjects. The subjects should say as many names of animals, fruits and vegetables as possible within 1 minute. A correct object will get 1 point, no point will be given if repeated.
Clock Drawing Task(CDT)
Time frame: From preoperative to 3 days after operation
Assess the cognitive function of the patient. CDT was used to evaluate the visual spatial structure ability of the subjects. The subjects need to draw the dial of the clock on paper and write the numbers in the correct position. Scoring method: ① Draw a closed circular outline, 1 point. ②The number display and sequence in the dial are correct, 2 points. ③The position of the hour and minute hand is correct, 1 point. To reduce the learning effect, the test time preoperative and postoperative in this study is drawn at 08:10 and 07:50 respectively.
12 secondary outcomes
Interleukin-6(IL-6)
Time frame: Baseline and on the 3rd day after the operation
S100 calcium proteinβ(S100β)
Time frame: Baseline and on the 3rd day after the operation
insulin-like growth factor-1( IGF-1 )
Time frame: Baseline and on the 3rd day after the operation
C-reactive protein(CRP)
Time frame: Baseline and on the 3rd day after the operation
Numerical pain score(NRS)
Time frame: on the third day after operation
Score of Branden pressure ulcer risk assessment scale(Branden)
Time frame: The seventh day after operation
Score of Barthel index (BI)
Time frame: The seventh day after operation
Telephone Interview for Cognitive Status-Modified(TICS-m)
Time frame: 1, 3, 6 months after operation.
Postoperative exhaust time
Time frame: The second day after operation
Postoperative defecation time
Time frame: The second day after operation
Postoperative eating time
Time frame: The second day after operation
The time of get out of bed for the first time after operation
Time frame: The second day after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 31765741Lin X, Chen Y, Zhang P, Chen G, Zhou Y, Yu X. The potential mechanism of postoperative cognitive dysfunction in older people. Exp Gerontol. 2020 Feb;130:110791. doi: 10.1016/j.exger.2019.110791. Epub 2019 Nov 23.
- Background: PubMed 32149824Deiner S, Liu X, Lin HM, Jacoby R, Kim J, Baxter MG, Sieber F, Boockvar K, Sano M. Does Postoperative Cognitive Decline Result in New Disability After Surgery? Ann Surg. 2021 Dec 1;274(6):e1108-e1114. doi: 10.1097/SLA.0000000000003764.
- Background: PubMed 34149572Liu J, Huang K, Zhu B, Zhou B, Ahmad Harb AK, Liu L, Wu X. Neuropsychological Tests in Post-operative Cognitive Dysfunction: Methods and Applications. Front Psychol. 2021 Jun 4;12:684307. doi: 10.3389/fpsyg.2021.684307. eCollection 2021.
- Background: PubMed 34425851Xi L, Fang F, Yuan H, Wang D. Transcutaneous electrical acupoint stimulation for postoperative cognitive dysfunction in geriatric patients with gastrointestinal tumor: a randomized controlled trial. Trials. 2021 Aug 23;22(1):563. doi: 10.1186/s13063-021-05534-9.
- Background: PubMed 22809061Ricci M, Graef S, Blundo C, Miller LA. Using the Rey Auditory Verbal Learning Test (RAVLT) to differentiate alzheimer's dementia and behavioural variant fronto-temporal dementia. Clin Neuropsychol. 2012;26(6):926-41. doi: 10.1080/13854046.2012.704073. Epub 2012 Jul 18.
- Background: PubMed 33049114Wessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.
- Background: PubMed 25120480Bertola L, Mota NB, Copelli M, Rivero T, Diniz BS, Romano-Silva MA, Ribeiro S, Malloy-Diniz LF. Graph analysis of verbal fluency test discriminate between patients with Alzheimer's disease, mild cognitive impairment and normal elderly controls. Front Aging Neurosci. 2014 Jul 29;6:185. doi: 10.3389/fnagi.2014.00185. eCollection 2014.
- Background: PubMed 32387111Leissing-Desprez C, Thomas E, Segaux L, Broussier A, Oubaya N, Marie-Nelly N, Laurent M, Cleret de Langavant L, Fromentin I, David JP, Bastuji-Garin S. Understated Cognitive Impairment Assessed with the Clock-Drawing Test in Community-Dwelling Individuals Aged >/=50 Years. J Am Med Dir Assoc. 2020 Nov;21(11):1658-1664. doi: 10.1016/j.jamda.2020.03.016. Epub 2020 May 6.
- Derived from this study: PubMed 40109717Yin W, Fang F, Zhang Y, Xi L. Timing of transcutaneous acupoint electrical stimulation for postoperative recovery in geriatric patients with gastrointestinal tumors: study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Mar 5;12:1497647. doi: 10.3389/fmed.2025.1497647. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous acupoint electrical stimulation in people with Postoperative Cognitive Dysfunction, run by Subei People's Hospital of Jiangsu Province 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 4 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: opening soon, as of the sponsor's last update on 20 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daorong - Wang, Ph.D (18051062590, daorong666@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination(MMSE) (time frame: From preoperative to 3 days after operation). The study lists 5 primary outcomes in all. 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 NCT05482477, which also lists 9 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 20 Sep 2024.