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

NCT ID: NCT07273864

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2024-03-20

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.

Detailed Description

This was a single-center, parallel-group, randomized controlled trial. Patients were stratified by injury severity according to the Glasgow Coma Scale (GCS 4-6 versus 7-8) and randomized 1:1 using a computer-generated sequence produced by an independent statistician.

Allocation was concealed with sequentially numbered opaque sealed envelopes opened only after informed consent had been signed by legal guardians.

Blinding of patients, families, and therapists was not feasible due to the visible auricular needles and stimulation device. Outcome assessors remained blinded throughout; they received uniform training, used scoring forms without intervention information, and were regularly supervised.

Both groups received conventional treatment (surgery when indicated, medication, nutritional support, acupuncture, and complication prevention) plus right median nerve electrical stimulation twice daily for 8 weeks (40 Hz, 300 ms pulse width, intensity gradually increased to 20 mA). The experimental group additionally received auricular press needle therapy at Heart, Shenmen, Sympathetic, and Subcortex acupoints (disposable sterile needles, 3 days on/1 day off cycle, repeated throughout the 8 weeks), with family members trained to massage the points three times daily for 10 minutes.

All staff completed standardized training and passed competency checks. Weekly supervision by a senior neurosurgeon ensured treatment fidelity, data integrity, and family compliance.

Outcome assessments were conducted within 24 hours of enrollment (baseline: demographics, Glasgow Coma Scale [GCS], Coma Recovery Scale-Revised [CRS-R], duration of consciousness disturbance, imaging findings, and vital signs), at 4 and 6 weeks (awakening status, GCS, CRS-R, adverse events, and treatment compliance), at 8 weeks (awakening rate, GCS, CRS-R, and family satisfaction), and at 12 weeks (1 month after completion of the 8-week intervention: Glasgow Outcome Scale [GOS] for long-term prognosis).

Data were recorded on standardized electronic case report forms with double-entry by two independent clerks. Discrepancies were resolved by referring to original records and the supervisor. The database was password-protected, accessible only to authorized personnel, and backed up weekly both on-site and off-site.

Safety was monitored daily and adverse events were graded and managed according to a predefined protocol. Sample size of 60 patients (30 per group) was calculated to detect an increase in 8-week awakening rate from 40 % to 70 % (α=0.05, two-sided; power=0.80; 10 % dropout).

Statistical analyses were performed using SPSS 27.0 and R 4.2.1. All tests were two-sided with statistical significance set at p < 0.05. The primary outcome (8-week awakening rate) was analyzed with the χ² test. Secondary outcomes were analyzed using repeated-measures ANOVA for GCS/CRS-R scores, Kaplan-Meier and log-rank test for time-to-awakening, Mann-Whitney U test or ordinal regression for GOS, and t-test/χ² test for family satisfaction. Both intention-to-treat (ITT) and per-protocol (PP) analyses were conducted as sensitivity analyses. Pre-specified subgroup analyses were performed according to initial injury severity (GCS 4-6 versus 7-8) and duration of consciousness disturbance before enrollment (< 5 days versus 5-10 days).

Conditions

Traumatic Brain Injury; Cerebral Hemorrhage

Study Design

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

Study Groups

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

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

Group Type: EXPERIMENTAL

Auricular Press-Needle Therapy

Intervention Type: 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.

Right Median Nerve Electrical Stimulation

Intervention Type: 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 Neurosurgical and Supportive Care

Intervention Type: 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 combined with right median nerve electrical stimulation.

Group Type: ACTIVE_COMPARATOR

Right Median Nerve Electrical Stimulation

Intervention Type: 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 Neurosurgical and Supportive Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Hai

OTHER

Sponsor Role: lead

Responsible Party

Li Hai

Chief Therapist, Department of Rehabilitation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hai N Li, Middle Initia

Role: STUDY_CHAIR

First Affiliated Hospital of Gannan Medical University

Locations

The First Affiliated Hospital of Gannan Medical University

Jiangxi, Ganzhou, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

LLSL-2022053105

Identifier Type: -

Identifier Source: org_study_id