Acute Ischemic StrokeNCT06540417
Study of the Effects of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
A study testing External trigeminal nerve stimulation in people with Acute Ischemic Stroke, run by Xidian University at 1 site in China.
Trial summary
In patients with ischemic stroke, the primary focus revolves around enhancing the neuroprotective and rehabilitative effects of external trigeminal nerve stimulation (eTNS) and elucidating its underlying central mechanisms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- External trigeminal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2024to 20 Dec 2024
- 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 over 18 years;
- Medically diagnosed with acute ischemic stroke;
- Ability to receive trigeminal nerve stimulation within 72 hours post-stroke onset;
- NIHSS (National Institutes of Health Stroke Scale) score ≥ 4;
- Signed informed consent form;
- Ability and willingness to comply with the study requirements.
Who cannot join
- History of ischemic or hemorrhagic stroke within the past 3 months;
- Patients in a comatose state;
- Severe allergic reaction to MR contrast agents or renal impairment, eGFR <30 ml/min, excluding the use of contrast agents;
- Pregnant or breastfeeding women;
- Any other life-threatening or severe medical condition that may interfere with the completion of the study protocol, including the 3-month follow-up;
- Exclusion from trigeminal nerve stimulation: patients with trigeminal neuralgia or facial pain;
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- Current or recent participation in other neuromodulation stimulation therapies within the past 3 months;
- Refusal to sign the informed consent form;
- Presence of contraindications related to MRI scanning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Neuroprotection and Rehabilitation Promotion of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
In patients with ischemic stroke, the primary focus revolves around enhancing the neuroprotective and rehabilitative effects of external trigeminal nerve stimulation (eTNS) and elucidating its underlying central mechanisms. Through clinical trials and neuroimaging studies, this research endeavors to 1) investigate the clinical impact of TNS on brain protection and 2) rehabilitation acceleration in ischemic stroke patients, while concurrently exploring the potential central nervous mechanisms involved. The ultimate aim is to contribute a novel therapeutic approach to the clinical management of acute ischemic stroke.
Read the detailed description
This study conducted a randomized controlled clinical trial with an intention to enroll 60 patients. Patients were randomly assigned in a 1:1 ratio to two groups: 1) External trigeminal nerve stimulation (eTNS) group (intervention group); 2) Standard treatment group (control group). eTNS was administered once daily for 30 consecutive days during the treatment period. The eTNS stimulation protocol entailed targeting the bilateral supraorbital region as the non-invasive stimulation site, with treatment administered for 30 days (once daily, during nighttime sleep for a minimum of 8 hours per day; stimulation parameters set at 120 Hz, 250 μs, 30s ON-30s OFF, with intensity adjusted to individual comfort levels). For the standard treatment group, a series of interventions excluding eTNS, as directed by the treating physician, were administered (including but not limited to medications and rehabilitation therapies). Blood samples and medical history information were collected at baseline. Imaging data were acquired from participants at baseline and 5 days post-treatment. Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI) were assessed at baseline, 5 days post-treatment, at the end of treatment, and at 1- and 2-month follow-ups. Additionally, the 9-item Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item scale (GAD-7), and Insomnia Severity Index (ISI) were administered at baseline, the end of treatment, and at 1- and 2-month follow-ups to evaluate participants' emotional well-being and sleep patterns. The recruited sample size met statistical requirements.
- Conditions
- Acute Ischemic Stroke
- Being tested
- External trigeminal nerve stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External trigeminal nerve stimulationDevice
The stimulation parameters were set to 120Hz, 250μs, 30s ON-30s OFF, with the intensity adjusted for patient comfort.
| Study group | Role | What they receive |
|---|---|---|
| eTNS treatment | Active comparator | Bilateral supraorbital regions were selected as the stimulation sites for external trigeminal nerve stimulation (eTNS). Receives: Device: External trigeminal nerve stimulation |
| Control treatment | No intervention | The standard treatment group received physician-directed treatment for acute ischemic stroke, which included medication and rehabilitation therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after five days of treatment
The National Institutes of Health Stroke Scale (NIHSS) is employed to evaluate the extent of functional impairment caused by stroke. Comprising 11 test items, the scale's scoring ranges from 0 to 42. Higher scores are indicative of more severe strokes and are positively correlated with the volume of cerebral damage caused by the stroke.
Response is defined as a decrease in NIHSS (National Institutes of Health Stroke Scale) score by 4 points or more, or a decrease to 0-1 points after treatment. The response rate is the proportion of participants whose NIHSS scores decrease by 4 points or more, or to 0-1 points, compared to baseline.
Measured: NIHSS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Secondary outcomes (10)
Infarct volume growth rate
Defined as the difference in infarct volume on day 5 compared to baseline, divided by the baseline infarct volume.
Measured: Imaging data will be collected twice within 90 days: at baseline (prior to participant enrollment) and on the fifth day of treatment.
Change in NIHSS scores
The National Institutes of Health Stroke Scale (NIHSS) is employed to evaluate the extent of functional impairment caused by stroke. Comprising 11 test items, the scale's scoring ranges from 0 to 42. Higher scores are indicative of more severe strokes and are positively correlated with the volume of cerebral damage caused by the stroke.
The change in NIHSS score will be determined by subtracting the baseline score from the score at each subsequent time point.
Measured: NIHSS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in mRS scores
The Modified Rankin Scale (mRS) is employed to assess the status of neurological function recovery in stroke patients. This scale is categorized into seven levels with a scoring range from 0 to 6. Each level corresponds to a specific score; higher scores indicate a poorer prognosis, with a score of 6 signifying death.
The change in mRS score will be calculated by subtracting the baseline score from the score at each subsequent time point.
Measured: mRS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in BI scores
The Barthel Index (BI) measures the ability of patients to perform daily living activities. Scores range from 0 to 100, with higher scores reflecting greater independence and less dependency.
The change in BI score will be calculated by subtracting the baseline score from the score at each subsequent time point.
Measured: BI will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in PHQ-9 scores
The Patient Health Questionnaire-9 (PHQ-9) encompasses nine items, each representing a different facet of depressive symptoms. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
The change in PHQ-9 score will be determined by subtracting the baseline score from the score at each subsequent time point.
Measured: PHQ-9 will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Change in GAD-7 scores
The Generalized Anxiety Disorder Scale (GAD-7) is used to assess the emotional state of patients. The Generalized Anxiety Disorder Scale (GAD-7) comprises seven items, with a total possible score ranging from 0 to 21. An elevated score suggests a more pronounced level of anxiety.
The change in GAD-7 score will be determined by subtracting the baseline score from the score at each subsequent time point.
Measured: GAD-7 will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Change in ISI scores
The Insomnia Severity Index （ISI） is utilized to assess the severity of insomnia and its impact on physical health, daily function, and quality of life. This scale includes seven items, with a total scoring range from 0 to 28. Higher scores denote more severe insomnia.
The change in ISI score will be determined by subtracting the baseline score from the score at each subsequent time point.
Measured: ISI will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Correlation Between Time to Treatment and Intervention Outcomes
The correlation between the hours from stroke onset to treatment and intervention outcomes (defined by NIHSS score improvement or no improvement) will be assessed.
Measured: The time from stroke onset to treatment will be recorded prior to enrollment.
Correlation Between Blood Inflammatory Markers and Stroke Severity and Intervention Outcomes
Blood samples will be collected at baseline (prior to participant enrollment) to measure levels of TNF-α and IL-6 (pg/ml). The correlation between these levels and intervention outcomes (defined by NIHSS score improvement or no improvement) will be analyzed.
Measured: Blood samples will be collected at baseline (prior to participant enrollment)
Correlation Between Medical History and Intervention Outcomes
Participants' medical history, including diabetes, hypertension, coronary artery disease, and history of cerebral infarction, will be collected at baseline to examine the relationship between medical history and the efficacy of the intervention.
Measured: Medical History will be collected at baseline (prior to participant enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start25 Jul 2024
- Primary completion1 Oct 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xidian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Qin, Xidian University
- Investigators
- Rui Zhao, Doctor, Principal investigator, Shaanxi Provincial People's HospitalWei Qin, Phd, Principal investigator, Xidian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540417
- Sponsor's protocol ID
- 20231210
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Neuroprotection and Rehabilitation Promotion of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT06540417
- Acronym / sponsor ID
- 20231210
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xidian UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 6 Aug 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.
In patients with ischemic stroke, the primary focus revolves around enhancing the neuroprotective and rehabilitative effects of external trigeminal nerve stimulation (eTNS) and elucidating its underlying central mechanisms. Through clinical trials and neuroimaging studies, this research endeavors to 1) investigate the clinical impact of TNS on brain protection and 2) rehabilitation acceleration in ischemic stroke patients, while concurrently exploring the potential central nervous mechanisms involved. The ultimate aim is to contribute a novel therapeutic approach to the clinical management of acute ischemic stroke.
Detailed description
This study conducted a randomized controlled clinical trial with an intention to enroll 60 patients. Patients were randomly assigned in a 1:1 ratio to two groups: 1) External trigeminal nerve stimulation (eTNS) group (intervention group); 2) Standard treatment group (control group). eTNS was administered once daily for 30 consecutive days during the treatment period. The eTNS stimulation protocol entailed targeting the bilateral supraorbital region as the non-invasive stimulation site, with treatment administered for 30 days (once daily, during nighttime sleep for a minimum of 8 hours per day; stimulation parameters set at 120 Hz, 250 μs, 30s ON-30s OFF, with intensity adjusted to individual comfort levels). For the standard treatment group, a series of interventions excluding eTNS, as directed by the treating physician, were administered (including but not limited to medications and rehabilitation therapies). Blood samples and medical history information were collected at baseline. Imaging data were acquired from participants at baseline and 5 days post-treatment. Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI) were assessed at baseline, 5 days post-treatment, at the end of treatment, and at 1- and 2-month follow-ups. Additionally, the 9-item Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item scale (GAD-7), and Insomnia Severity Index (ISI) were administered at baseline, the end of treatment, and at 1- and 2-month follow-ups to evaluate participants' emotional well-being and sleep patterns. The recruited sample size met statistical requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTNS treatment | Active comparator | Device: External trigeminal nerve stimulationBilateral supraorbital regions were selected as the stimulation sites for external trigeminal nerve stimulation (eTNS). |
| Control treatment | No intervention | –The standard treatment group received physician-directed treatment for acute ischemic stroke, which included medication and rehabilitation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years;
- Medically diagnosed with acute ischemic stroke;
- Ability to receive trigeminal nerve stimulation within 72 hours post-stroke onset;
- NIHSS (National Institutes of Health Stroke Scale) score ≥ 4;
- Signed informed consent form;
Key exclusion criteria (9 listed)
- History of ischemic or hemorrhagic stroke within the past 3 months;
- Patients in a comatose state;
- Severe allergic reaction to MR contrast agents or renal impairment, eGFR <30 ml/min, excluding the use of contrast agents;
- Pregnant or breastfeeding women;
- Any other life-threatening or severe medical condition that may interfere with the completion of the study protocol, including the 3-month follow-up;
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 |
|---|---|---|
| External trigeminal nerve stimulationThe stimulation parameters were set to 120Hz, 250μs, 30s ON-30s OFF, with the intensity adjusted for patient comfort. | Device | eTNS treatment |
Primary outcome
Response rate after five days of treatment
Time frame: NIHSS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
The National Institutes of Health Stroke Scale (NIHSS) is employed to evaluate the extent of functional impairment caused by stroke. Comprising 11 test items, the scale's scoring ranges from 0 to 42. Higher scores are indicative of more severe strokes and are positively correlated with the volume of cerebral damage caused by the stroke. Response is defined as a decrease in NIHSS (National Institutes of Health Stroke Scale) score by 4 points or more, or a decrease to 0-1 points after treatment. The response rate is the proportion of participants whose NIHSS scores decrease by 4 points or more, or to 0-1 points, compared to baseline.
10 secondary outcomes
Infarct volume growth rate
Time frame: Imaging data will be collected twice within 90 days: at baseline (prior to participant enrollment) and on the fifth day of treatment.
Change in NIHSS scores
Time frame: NIHSS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in mRS scores
Time frame: mRS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in BI scores
Time frame: BI will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.
Change in PHQ-9 scores
Time frame: PHQ-9 will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Change in GAD-7 scores
Time frame: GAD-7 will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Change in ISI scores
Time frame: ISI will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
Correlation Between Time to Treatment and Intervention Outcomes
Time frame: The time from stroke onset to treatment will be recorded prior to enrollment.
Correlation Between Blood Inflammatory Markers and Stroke Severity and Intervention Outcomes
Time frame: Blood samples will be collected at baseline (prior to participant enrollment)
Correlation Between Medical History and Intervention Outcomes
Time frame: Medical History will be collected at baseline (prior to participant enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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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.
Rui Zhao, Doctor principal investigator
Shaanxi Provincial People's Hospital
Wei Qin, Phd principal investigator
Xidian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External trigeminal nerve stimulation in people with Acute Ischemic Stroke, run by Xidian University 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 20 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate after five days of treatment (time frame: NIHSS will be assessed five times within 90 days: at baseline (prior to participant enrollment), and on days 5, 30, 60, and 90 post-enrollment.). 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 20 Jul 2025.