Effect of Median Nerve Electrical Stimulation Combined With Auricular Acupuncture on Consciousness Disturbance in Patients With Craniocerebral Injury

NCT07273864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-10

No results posted yet for this study

Summary

This study aims to evaluate the effects of auricular press needle therapy, combined with conventional treatment and median nerve electrical stimulation, on promoting arousal and neurological recovery in patients with disorders of consciousness after traumatic brain injury.

Sixty patients with a Glasgow Coma Scale (GCS) score of 4-8 were enrolled and randomly assigned in a 1:1 ratio to a control group or an experimental group (30 patients each). Both groups received standard conventional treatment (including surgery when indicated, medications, nutritional support, acupuncture, and complication prevention) combined with median nerve electrical stimulation. The experimental group received auricular press needle therapy (at Heart, Shenmen, Sympathetic, and Subcortex acupoints) on top of the same interventions, and family members were trained to perform daily acupoint massage.

The GCS score and Coma Recovery Scale-Revised (CRS-R) score were assessed at baseline, 4 weeks, 6 weeks, and 8 weeks after the start of intervention, and the arousal rate was recorded. The Glasgow Outcome Scale (GOS) was used to evaluate prognosis at 1 month after the end of treatment, and family satisfaction was assessed using a Likert scale at 8 weeks post-intervention. Data were analyzed using SPSS Statistics 27.0, with statistical significance set at p \< 0.05.

Conditions

Interventions

OTHER

Conventional Neurosurgical and Supportive Care

Routine comprehensive management for severe traumatic brain injury, including surgical intervention when indicated, intracranial pressure monitoring if needed, neuroprotective and symptomatic medications (e.g., anti-epileptic drugs), nutritional support, complication prevention, nursing care, and conventional rehabilitation therapy. All care was provided in accordance with institutional standard protocols.

DEVICE

Right Median Nerve Electrical Stimulation

The multifunctional electrical therapy apparatus (Model MT1023; Shenzhen Dongdixin Technology Co., Ltd.) was used. A single skin electrode was placed 2 cm proximal to the right wrist crease on the volar forearm. Stimulation parameters: asymmetric biphasic (direct current) square wave, intensity up to 20 mA, pulse width 300 ms, frequency 40 Hz, intermittent mode (20 seconds on, 40 seconds off). Sessions lasted 60 minutes and were delivered twice daily, 7 days per week, for 8 weeks.

DEVICE

Auricular Press-Needle Therapy

Disposable sterile press needles (0.2 mm × 0.5 mm thumbtack type) were inserted bilaterally at the auricular acupoints Shenmen (TF4) and Subcortex/Brain (AT4) \[some records also included Heart (CO15) and Sympathetic\]. Needles were retained for 48 hours, replaced every 2-3 days, and the cycle was repeated for the entire 8-week treatment period. Family members were trained to massage each point three times daily.

Sponsors & Collaborators

  • Li Hai

    lead OTHER

Principal Investigators

  • Hai N Li, Middle Initia · First Affiliated Hospital of Gannan Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
86 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-11-30
Completion
2024-03-20

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273864 on ClinicalTrials.gov