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

NCT07273864 | Completed

• 1 other identifier: LLSL-2022053105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury; Cerebral Hemorrhage

Keywords

Traumatic Brain Injury; Median Nerve Electrical Stimulation; Disorders of Consciousness; Promotion of Arousal; Ear Acupoint Press-Needl

Outcome Measures

Primary Outcomes (1)

• Awakening Rate of Patients with Consciousness Disorder After Traumatic Brain Injury (TBI)

  1. Description Primary outcome is awakening rate at 8 weeks post-intervention in TBI patients with consciousness disorder (GCS 4-8). "Awakening" = independent eye-opening ≥30s, or clear responses (limb retraction, simple verbal answers) to verbal/pain stimuli, confirmed by 2 attending physicians. 2. Time Frame 8 weeks after intervention start (end of full course). 3. Assessment Method Record weekly awakening status during 8-week intervention; Count awakened patients in Arm 1 (control) and Arm 2 (experimental) at week 8; Calculate rate: (Awakened patients / Total patients per group) × 100%. 4. Rationale Awakening is core rehabilitation goal for these patients, directly reflecting intervention efficacy in consciousness recovery. More intuitive and clinically meaningful than other indicators (e.g., GCS) for evaluating core therapeutic effect.

  8 weeks after the start of the intervention (which is the end of the full intervention course for the study).

Secondary Outcomes (1)

• Change in Glasgow Coma Scale (GCS) Score

  Baseline (pre-intervention), 4 weeks, 6 weeks, 8 weeks post-intervention.

Study Arms (2)

Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy

EXPERIMENTAL

Conventional treatment combined with right median nerve electrical stimulation and auricular press-needle therapy.

Other: Conventional Neurosurgical and Supportive Care; Device: Right Median Nerve Electrical Stimulation; Device: Auricular Press-Needle Therapy

Conventional Treatment + Median Nerve Electrical Stimulation

ACTIVE COMPARATOR

Conventional treatment combined with right median nerve electrical stimulation.

Other: Conventional Neurosurgical and Supportive Care; Device: Right Median Nerve Electrical Stimulation

Interventions

Conventional Neurosurgical and Supportive Care OTHER

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.

Conventional Treatment + Median Nerve Electrical Stimulation; Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy

Right Median Nerve Electrical Stimulation DEVICE

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.

Conventional Treatment + Median Nerve Electrical Stimulation; Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy

Auricular Press-Needle Therapy DEVICE

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.

Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy

Eligibility Criteria

• Age: 20 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disorder of consciousness following traumatic brain injury
• Stable vital signs with no evidence of active bleeding
• Glasgow Coma Scale (GCS) score between 4 and 8 (inclusive)
• No severe vital organ dysfunction and normal cardiac function
• Time from injury to enrollment ≤ 10 days
• No prior history of traumatic brain injury, epilepsy, or pregnancy

You may not qualify if:

• Presence of other critical illnesses (e.g., severe cardiovascular, hepatic, or renal disease)
• Known allergy to the electrodes or adhesive patches used in electrical stimulation
• Lack of cooperation or refusal by the patient's legal guardian/family members

Sponsors & Collaborators

• Li Hai: lead

Study Sites (1)

The First Affiliated Hospital of Gannan Medical University

Jiangxi, Ganzhou, 341000, China

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage; Consciousness Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hai N Li, Middle Initia

  First Affiliated Hospital of Gannan Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Therapist, Department of Rehabilitation

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: December 10, 2025
• Study Start: February 10, 2022
• Primary Completion: November 30, 2023
• Study Completion: March 20, 2024
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)