Study of the Effects of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients

NCT ID: NCT06540417

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2024-12-20

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

eTNS treatment

Bilateral supraorbital regions were selected as the stimulation sites for external trigeminal nerve stimulation (eTNS).

Group Type: ACTIVE_COMPARATOR

External trigeminal nerve stimulation

Intervention Type: DEVICE

The stimulation parameters were set to 120Hz, 250μs, 30s ON-30s OFF, with the intensity adjusted for patient comfort.

Control treatment

The standard treatment group received physician-directed treatment for acute ischemic stroke, which included medication and rehabilitation therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

External trigeminal nerve stimulation

The stimulation parameters were set to 120Hz, 250μs, 30s ON-30s OFF, with the intensity adjusted for patient comfort.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xidian University

OTHER

Sponsor Role: lead

Responsible Party

Wei Qin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shaanxi Provincial People&#39;s Hospital

Wei Qin, Phd

Role: PRINCIPAL_INVESTIGATOR

Xidian University

Locations

Xidian University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

20231210

Identifier Type: -

Identifier Source: org_study_id