Type 2 DiabetesNCT07642518
Transcutaneous Auricular Vagus Nerve Stimulation in Type 2 Diabetes With Mild Cognitive Impairment
A study testing active transcutaneous auricular vagus nerve stimulation in people with Type 2 Diabetes and Mild Cognitive Impairment, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial. A total of 38 patients with type 2 diabetes and mild cognitive impairment were enrolled and randomly assigned in a 1:1 ratio to either the treatment group (receiving active transcutaneous auricular vagus… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Mild Cognitive Impairment
- What is being tested?
- active transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 31 Dec 2027
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Meets criteria for mild cognitive impairment
- Aged 40 to 75 years, with no gender restrictions
- HbA1c levels between 6.5% and 9.0%
- At least 6 years of formal education
- Able to cooperate with and complete all cognitive and functional assessments
- Right-handed
- Voluntary provision of written informed consent
Who cannot join
- Concomitant use of GLP-1 receptor agonists, Alzheimer's disease medications, anti-Parkinson's medications, antiepileptic drugs, or antipsychotic drugs within 3 months prior to screening
- Presence of dementia-related neurological disorders; current or history of clinically significant psychiatric disorders within the past 2 years (e.g., schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, personality disorders)
- CNS diseases, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc
- Severe sinusitis, nasal and sinus polyps, space-occupying lesions such as skull base or nasopharyngeal tumors; congenital diseases or history of trauma of the nose, maxillofacial region, or skull base that affect olfactory function; presence of upper respiratory tract infection symptoms (e.g., nasal congestion, rhinorrhea, fever) on the day of the MRI scan
- Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hypoglycemic coma, etc
- Severe impairment of major organ function (e.g., heart, liver, kidneys), including any of the following: ALT and/or AST > 3×ULN. eGFR < 45 mL/min/1.72 m² (CKD-EPI). History of unstable angina, myocardial infarction, or NYHA Class II or higher heart failure within 3 months prior to screening
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- Concurrent major illnesses, such as active or untreated malignancies, or malignancies in clinical remission for less than 5 years.
- Contraindications for MRI scans (e.g., implanted metallic prostheses, claustrophobia); presence of cardiac pacemakers or other implantable medical devices; severe infection or ulceration of the auricular skin
- Pregnant or lactating women
- History of alcohol abuse, defined as an average weekly alcohol consumption exceeding 21 units for males and 14 units for females (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of distilled spirits/liquor)
- Any other conditions or factors that, in the opinion of the investigator, may confound the efficacy or safety evaluation of the study, making the participant unsuitable for enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Type 2 Diabetes and Mild Cognitive Impairment: A Single-Center, Randomized, Double-Blind, Sham-Controlled Clinical Trial
This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial. A total of 38 patients with type 2 diabetes and mild cognitive impairment were enrolled and randomly assigned in a 1:1 ratio to either the treatment group (receiving active transcutaneous auricular vagus nerve stimulation) or the sham control group (receiving sham transcutaneous auricular vagus nerve stimulation). The primary objective of this study is to evaluate the potential disease-modifying effects of transcutaneous auricular vagus nerve stimulation on cognitive impairment in patients with type 2 diabetes.
Read the detailed description
This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial aimed at investigating the potential disease-modifying effects of transcutaneous auricular vagus nerve stimulation (taVNS) on cognitive impairment in 38 patients with type 2 diabetes mellitus (T2DM) complicated by mild cognitive impairment. Participants will be randomly assigned in a 1:1 ratio to receive either active taVNS (stimulation frequency: 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute; 30 minutes per session, twice daily) or sham stimulation for 5 days per week. All participants will continue to receive treatment based on their original glucose-lowering therapies. The primary objective of the study is to evaluate improvements in cognitive function, while secondary endpoints include structural and functional brain changes, metabolic improvements, neurodegenerative biomarkers, and safety outcomes.
Participants will undergo comprehensive cognitive and metabolic assessments at baseline, followed by a safety visit at Week 12 to monitor adverse events, treatment adherence, and metabolic parameters. The comprehensive evaluation at Week 24 will include cognitive assessments, neuroimaging, and metabolic profiling. During the study period, investigators will conduct weekly follow-ups via telephone or WeChat, and participants will attend monthly in-clinic visits to complete examinations such as capillary blood glucose, blood pressure, and heart rate, as well as to be inquired about treatment adherence and adverse reactions. All rationales for decision-making and efficacy evaluations must be thoroughly documented.
- Conditions
- Type 2 Diabetes, Mild Cognitive Impairment
- Being tested
- active transcutaneous auricular vagus nerve stimulation, sham transcutaneous auricular vagus nerve stimulation
- Keywords
- Type 2 Diabetes, Mild Cognitive Impairment, Cognitive Impairment, Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active transcutaneous auricular vagus nerve stimulationDevice
After disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the active stimulation group, the actual functional electrodes delivering the current are positioned at the cymba conchae and cavum conchae. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks.
sham transcutaneous auricular vagus nerve stimulationDevice
After disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the sham stimulation group, the actual functional electrodes delivering the current are positioned at the earlobe. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| active taVNS | Experimental | After disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the active stimulation group, the actual functional electrodes delivering the current are positioned at the cymba conchae and cavum conchae. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks. Receives: Device: active transcutaneous auricular vagus nerve stimulation |
| sham taVNS | Sham comparator | After disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the sham stimulation group, the actual functional electrodes delivering the current are positioned at the earlobe. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks. Receives: Device: sham transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Scale (MoCA) score
The MoCA is a comprehensive endpoint focusing on the cognitive domain. It integrates multidimensional assessments of core cognitive functions (including subscale scores for visuospatial/executive function, naming, attention, language, abstraction, delayed recall, and orientation), yielding a total score range of 0-30.The calculation formula is:MoCA Score = Subscale Scores+ Educational Correction(Note: If the participant's formal education is ≤12 years, 1 point is added to the sum of the subscale scores, with the maximum total score capped at 30).Lower MoCA scores indicate more severe global cognitive impairment in the participant.
Measured: Baseline, and Week 24
Secondary outcomes (20)
Change in score of Mini-Mental State Examination (MMSE)
The MMSE contains a total of 30 items that assess orientation, registration, attention and calculation, recall, and language, with a score range from 0 to 30. Generally, a higher MMSE score reflects a better cognitive function.
Measured: from baseline to week 24 of treatment
Changes in total score of RBANS
The RBANS (Chinese version) is a brief neuropsychological screening battery with established test-retest reliability and age-appropriate normative data, which consists of 12 task tests assessing 5 cognitive domains, namely immediate memory, visuospatial/ constructional, language, attention and delayed memory, with a score range from 40 to 160. A higher RBANS score reflects a better global cognitive function.
Measured: from baseline to week 24 of treatment
Change in the RBANS index score of immediate memory
The RBANS (Chinese version) is a brief neuropsychological screening battery with established test-retest reliability and age-appropriate normative data. The RBANS includes 12 sub-tests that generate five age-adjusted index scores and a total score. The five indices include immediate memory (consisting of list learning and story memory tests), visuospatial/constructional domain (consisting of figure copying and line orientation tests), language (consisting of picture naming and semantic fluency tests), attention (consisting of digit span and coding tests) and delayed memory (consisting of list recall, story recall, figure recall and list recognition tests). Generally, a higher index score reflects a better cognitive subdomain function.
Measured: from baseline to week 24 of treatment
Change in the RBANS index score of visuospatial/constructional
Measurements and instruments are the same as the RBANS index score of immediate memory.
Measured: from baseline to week 24 of treatment
Change in the RBANS index score of language
Measurements and instruments are the same as the RBANS index score of immediate memory.
Measured: from baseline to week 24 of treatment
Change in the RBANS index score of attention
Measurements and instruments are the same as the RBANS index score of immediate memory.
Measured: from baseline to week 24 of treatment
Change in the RBANS index score of delayed memory
Measurements and instruments are the same as the RBANS index score of immediate memory.
Measured: from baseline to week 24 of treatment
Change in aggregate time to test completion for Trail Making Test (TMT)
The TMT is a validated timed measure of processing speed, which consists of part A and part B (TMT-A and TMT-B). The time limits for performing the TMT-A and TMT-B are 180 and 300 seconds, respectively. Processing speed is estimated by the aggregate time in seconds to complete TMT-A and TMT-B such that less time indicate faster processing speed.
Measured: from baseline to week 24 of treatment
Change in aggregate time to test completion for Victoria Stroop Color-Word Test
The Victoria Stroop Color-Word Test is a well-known measure of executive function. There are three indices including Stroop-dot, Stroop-word and Stroop-color word in the test. The color task consists of colored dots; the word task comprises ordinary words that are unrelated to the meaning of color; the color-word task consists of words written in color that indicate the meaning of the color, but the color of these words differs from the meaning of the word itself. The participants were asked to quickly read the color of the dots or Chinese words on the cards. The sum of consuming time taken to read the three cards is used as an index of executive function performance. Less time indicates better executive function.
Measured: from baseline to week 24 of treatment
Change in Total Brain Volume
The change in total brain volume evaluated by structural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Measured: from baseline to week 24 of treatment
Change in Total White Matter Volume
The change in total white matter volume evaluated by structural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Measured: from Baseline to Week 24 of treatment
Change in Total Gray Matter Volume
The change in total gray matter volume evaluated by structural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Measured: from Baseline to Week 24 of treatment
Change in Total White Matter Lesion Volume
The change in total white matter lesion volume evaluated by sturctural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Measured: from Baseline to Week 24 of treatment
Change in Cortical Gray Matter Lobar Volumes
The change in cortical gray matter lobar volumes evaluated by sturctural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Measured: from Baseline to Week 24 of treatment
Change in Subcortical Nuclei Volumes
The change in subcortical nuclei volumes evaluated by stuctural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Measured: from Baseline to Week 24 of treatment
Change in Blood-Based Neurodegeneration Biomarkers
The change in blood-based neurodegeneration biomarkers (includingAmyloid-β (Aβ42/40 ratio), Phosphorylated tau (p-tau217), Glial fibrillary acidic protein (GFAP), and Neurofilament light chain (NfL), etc.）evaluated by Simoa from baseline to Week 76 will be compared between the treatment group and the placebo group.
Measured: from Baseline to Week 24 of treatment
Change in Heart Rate Variability
Change in heart rate variability from baseline to Week 24 will be assessed using time-domain and/or frequency-domain heart rate variability analysis
Measured: from Baseline to Week 24 of treatment
Change in Cardiovascular Autonomic Reflex Test Result
Change in cardiovascular autonomic reflex function from baseline to Week 24 will be assessed using standardized cardiovascular autonomic reflex testing
Measured: from Baseline to Week 24 of treatment
Change in Glycated Haemoglobin (HbA1c) Levels
Change in HbA1c levels from baseline to weeks 24
Measured: from Baseline to Week 24 of treatment
Change in fasting insulin
Fasting insulin
Measured: from baseline to weeks 24 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start20 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruan jianguo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642518
- Sponsor's protocol ID
- 2026-0451-01
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Type 2 Diabetes and Mild Cognitive Impairment: A Single-Center, Randomized, Double-Blind, Sham-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07642518
- Acronym / sponsor ID
- 2026-0451-01
- Conditions
- Type 2 Diabetes, Mild Cognitive Impairment
- Keywords
- Type 2 Diabetes, Mild Cognitive Impairment, Cognitive Impairment, Transcutaneous Auricular Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 2026 (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.
This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial. A total of 38 patients with type 2 diabetes and mild cognitive impairment were enrolled and randomly assigned in a 1:1 ratio to either the treatment group (receiving active transcutaneous auricular vagus nerve stimulation) or the sham control group (receiving sham transcutaneous auricular vagus nerve stimulation). The primary objective of this study is to evaluate the potential disease-modifying effects of transcutaneous auricular vagus nerve stimulation on cognitive impairment in patients with type 2 diabetes.
Detailed description
This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial aimed at investigating the potential disease-modifying effects of transcutaneous auricular vagus nerve stimulation (taVNS) on cognitive impairment in 38 patients with type 2 diabetes mellitus (T2DM) complicated by mild cognitive impairment. Participants will be randomly assigned in a 1:1 ratio to receive either active taVNS (stimulation frequency: 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute; 30 minutes per session, twice daily) or sham stimulation for 5 days per week. All participants will continue to receive treatment based on their original glucose-lowering therapies. The primary objective of the study is to evaluate improvements in cognitive function, while secondary endpoints include structural and functional brain changes, metabolic improvements, neurodegenerative biomarkers, and safety outcomes.
Participants will undergo comprehensive cognitive and metabolic assessments at baseline, followed by a safety visit at Week 12 to monitor adverse events, treatment adherence, and metabolic parameters. The comprehensive evaluation at Week 24 will include cognitive assessments, neuroimaging, and metabolic profiling. During the study period, investigators will conduct weekly follow-ups via telephone or WeChat, and participants will attend monthly in-clinic visits to complete examinations such as capillary blood glucose, blood pressure, and heart rate, as well as to be inquired about treatment adherence and adverse reactions. All rationales for decision-making and efficacy evaluations must be thoroughly documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active taVNS | Experimental | Device: active transcutaneous auricular vagus nerve stimulationAfter disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the active stimulation group, the actual functional electrodes delivering the current are positioned at the cymba conchae and cavum conchae. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks. |
| sham taVNS | Sham comparator | Device: sham transcutaneous auricular vagus nerve stimulationAfter disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the sham stimulation group, the actual functional electrodes delivering the current are positioned at the earlobe. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes mellitus
- Meets criteria for mild cognitive impairment
- Aged 40 to 75 years, with no gender restrictions
- HbA1c levels between 6.5% and 9.0%
- At least 6 years of formal education
Key exclusion criteria (11 listed)
- Concomitant use of GLP-1 receptor agonists, Alzheimer's disease medications, anti-Parkinson's medications, antiepileptic drugs, or antipsychotic drugs within 3 months prior to screening
- Presence of dementia-related neurological disorders; current or history of clinically significant psychiatric disorders within the past 2 years (e.g., schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, personality disorders)
- CNS diseases, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc
- Severe sinusitis, nasal and sinus polyps, space-occupying lesions such as skull base or nasopharyngeal tumors; congenital diseases or history of trauma of the nose, maxillofacial region, or skull base that affect olfactory function; presence of upper respiratory tract infection symptoms (e.g., nasal congestion, rhinorrhea, fever) on the day of the MRI scan
- Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hypoglycemic coma, etc
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 |
|---|---|---|
| active transcutaneous auricular vagus nerve stimulationAfter disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the active stimulation group, the actual functional electrodes delivering the current are positioned at the cymba conchae and cavum conchae. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks. | Device | active taVNS |
| sham transcutaneous auricular vagus nerve stimulationAfter disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the sham stimulation group, the actual functional electrodes delivering the current are positioned at the earlobe. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks. | Device | sham taVNS |
Primary outcome
Montreal Cognitive Assessment Scale (MoCA) score
Time frame: Baseline, and Week 24
The MoCA is a comprehensive endpoint focusing on the cognitive domain. It integrates multidimensional assessments of core cognitive functions (including subscale scores for visuospatial/executive function, naming, attention, language, abstraction, delayed recall, and orientation), yielding a total score range of 0-30.The calculation formula is:MoCA Score = Subscale Scores+ Educational Correction(Note: If the participant's formal education is ≤12 years, 1 point is added to the sum of the subscale scores, with the maximum total score capped at 30).Lower MoCA scores indicate more severe global cognitive impairment in the participant.
20 secondary outcomes
Change in score of Mini-Mental State Examination (MMSE)
Time frame: from baseline to week 24 of treatment
Changes in total score of RBANS
Time frame: from baseline to week 24 of treatment
Change in the RBANS index score of immediate memory
Time frame: from baseline to week 24 of treatment
Change in the RBANS index score of visuospatial/constructional
Time frame: from baseline to week 24 of treatment
Change in the RBANS index score of language
Time frame: from baseline to week 24 of treatment
Change in the RBANS index score of attention
Time frame: from baseline to week 24 of treatment
Change in the RBANS index score of delayed memory
Time frame: from baseline to week 24 of treatment
Change in aggregate time to test completion for Trail Making Test (TMT)
Time frame: from baseline to week 24 of treatment
Change in aggregate time to test completion for Victoria Stroop Color-Word Test
Time frame: from baseline to week 24 of treatment
Change in Total Brain Volume
Time frame: from baseline to week 24 of treatment
Change in Total White Matter Volume
Time frame: from Baseline to Week 24 of treatment
Change in Total Gray Matter Volume
Time frame: from Baseline to Week 24 of treatment
Change in Total White Matter Lesion Volume
Time frame: from Baseline to Week 24 of treatment
Change in Cortical Gray Matter Lobar Volumes
Time frame: from Baseline to Week 24 of treatment
Change in Subcortical Nuclei Volumes
Time frame: from Baseline to Week 24 of treatment
Change in Blood-Based Neurodegeneration Biomarkers
Time frame: from Baseline to Week 24 of treatment
Change in Heart Rate Variability
Time frame: from Baseline to Week 24 of treatment
Change in Cardiovascular Autonomic Reflex Test Result
Time frame: from Baseline to Week 24 of treatment
Change in Glycated Haemoglobin (HbA1c) Levels
Time frame: from Baseline to Week 24 of treatment
Change in fasting insulin
Time frame: from baseline to weeks 24 of treatment
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 11 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing active transcutaneous auricular vagus nerve stimulation in people with Type 2 Diabetes and Mild Cognitive Impairment, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 8 inclusion and 11 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jianguo Ruan, MD (86-25-83-106666, medrjg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment Scale (MoCA) score (time frame: Baseline, and Week 24). 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 11 Jun 2026.