Clinical trial NCT06540417: Study of the Effects of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
Official title: Study of the Neuroprotection and Rehabilitation Promotion of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Xidian University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Response rate after five days of treatment
timeFrame: 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:
measure: Infarct volume growth rate
timeFrame: Imaging data will be collected twice within 90 days: at baseline (prior to participant enrollment) and on the fifth day of treatment.
measure: Change in NIHSS scores
timeFrame: 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.
measure: Change in mRS scores
timeFrame: 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.
measure: Change in BI scores
timeFrame: 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.
measure: Change in PHQ-9 scores
timeFrame: 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.
measure: Change in GAD-7 scores
timeFrame: 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.
measure: Change in ISI scores
timeFrame: ISI will be assessed four times within 90 days: at baseline (prior to participant enrollment), and on days 30, 60, and 90 post-enrollment.
measure: Correlation Between Time to Treatment and Intervention Outcomes
timeFrame: The time from stroke onset to treatment will be recorded prior to enrollment.
measure: Correlation Between Blood Inflammatory Markers and Stroke Severity and Intervention Outcomes
timeFrame: Blood samples will be collected at baseline (prior to participant enrollment)
measure: Correlation Between Medical History and Intervention Outcomes
timeFrame: Medical History will be collected at baseline (prior to participant enrollment)
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xidian University
state: Shaanxi
Study officials:
affiliation: Shaanxi Provincial People&#39;s Hospital
name: Rui Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xidian University
name: Wei Qin, Phd
role: PRINCIPAL_INVESTIGATOR
References: