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

NCT06540417 | Completed

• 1 other identifier: 20231210
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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.

Study Arms (2)

eTNS treatment

ACTIVE COMPARATOR

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

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.

Interventions

External trigeminal nerve stimulation DEVICE

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

eTNS treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Xidian University: lead

Study Sites (1)

Xidian University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rui Zhao, Doctor

  Shaanxi Provincial People&#39;s Hospital

  PRINCIPAL INVESTIGATOR

• Wei Qin, Phd

  Xidian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 6, 2024
• Study Start: July 25, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 20, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (1)