Traumatic Brain InjuryANECT-CCINCT07273864
Effect of Median Nerve Electrical Stimulation Combined With Auricular Acupuncture on Consciousness Disturbance in Patients With Craniocerebral Injury
A study testing Conventional Neurosurgical and Supportive Care, Right Median Nerve Electrical Stimulation and Auricular Press-Needle Therapy in people with Traumatic Brain Injury and Cerebral Hemorrhage, run by Li Hai at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 86 years
- Conditions the study is for
- Traumatic Brain Injury, Cerebral Hemorrhage
- What is being tested?
- Conventional Neurosurgical and Supportive Care, Right Median Nerve Electrical Stimulation and Auricular Press-Needle Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Gannan Medical University
Jiangxi, Ganzhou, 341000
About this study
Official title: A Randomized Controlled Trial of Auricular Thumbtack Needle Therapy Combined With Conventional Treatment and Median Nerve Electrical Stimulation on Consciousness Recovery Prognosis and Family Satisfaction in Craniocerebral Injury Patients With Consciousness Disorder
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.
Read the 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
- Being tested
- Conventional Neurosurgical and Supportive Care, Right Median Nerve Electrical Stimulation, Auricular Press-Needle Therapy
- Keywords
- Traumatic Brain Injury, Median Nerve Electrical Stimulation, Disorders of Consciousness, Promotion of Arousal, Ear Acupoint Press-Needl
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Neurosurgical and Supportive CareOther
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.
Right Median Nerve Electrical StimulationDevice
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.
Auricular Press-Needle TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Neurosurgical and Supportive Care; Device: Right Median Nerve Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awakening Rate of Patients with Consciousness Disorder After Traumatic Brain Injury (TBI)
- 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.
- Time Frame 8 weeks after intervention start (end of full course).
- 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%.
- 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.
Measured: 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
Description: Change in GCS score (3-15 points; higher = better neurofunction) from baseline to 4, 6, 8 weeks post-intervention.
Time Frame: Baseline (pre-intervention), 4 weeks, 6 weeks, 8 weeks post-intervention.
Method: Trained nurses assess GCS (eye-opening, verbal, motor responses); calculate score changes (post-intervention - baseline).
Rationale: Supplements awakening rate, quantifies gradual neurofunctional improvement over intervention.
Measured: Baseline (pre-intervention), 4 weeks, 6 weeks, 8 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start10 Feb 2022
- Primary completion30 Nov 2023
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li Hai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Hai, First Affiliated Hospital of Gannan Medical University
- Investigators
- Hai N Li, Middle Initia, Study chair, First Affiliated Hospital of Gannan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273864
- Sponsor's protocol ID
- LLSL-2022053105
- Acronym
- ANECT-CCI
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Privacy Protection: Collected IPD includes sensitive personal health information. Per China's Personal Information Protection Law and hospital ethical requirements, sharing IPD risks unauthorized disclosure, violating patients' information security rights. Informed Consent Limitations : Participants' signed consent only authorizes IPD use for this study's research goals, not sharing with external parties. Without additional ethical approval and patient re-consent, sharing is non-compliant with ethical commitments. Data Security \& Integrity : IPD is managed under The First Affiliated Hospital of Gannan Medical University's security system. External sharing may cause data tampering, improper use, or loss, compromising result integrity and analysis credibility. Future IPD sharing (e.g., collaborative research) will require hospital Ethics Committee approval, patient re-consent, and strict de-identification/transfer protocols to meet legal and ethical standards.
Publications
Li H, Song W, Zeng S, Liu L, Liu C, Lu H. Promoting Consciousness Recovery in Patients with Acquired Brain Injury Through Multimodal Sensory Stimulation: A Randomized Controlled Trial of Median Nerve and Auricular Stimulation. Neurocrit Care. 2026 May 28. doi: 10.1007/s12028-026-02543-x. Online ahead of print.
PubMed 42209901
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Auricular Thumbtack Needle Therapy Combined With Conventional Treatment and Median Nerve Electrical Stimulation on Consciousness Recovery Prognosis and Family Satisfaction in Craniocerebral Injury Patients With Consciousness Disorder
- ClinicalTrials.gov ID
- NCT07273864
- Acronym / sponsor ID
- ANECT-CCI / LLSL-2022053105
- Conditions
- Traumatic Brain Injury, Cerebral Hemorrhage
- Keywords
- Traumatic Brain Injury, Median Nerve Electrical Stimulation, Disorders of Consciousness, Promotion of Arousal, Ear Acupoint Press-Needl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Li HaiUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy | Experimental | Other: Conventional Neurosurgical and Supportive Care, Device: Right Median Nerve Electrical Stimulation, Device: Auricular Press-Needle TherapyConventional treatment combined with right median nerve electrical stimulation and auricular press-needle therapy. |
| Conventional Treatment + Median Nerve Electrical Stimulation | Active comparator | Other: Conventional Neurosurgical and Supportive Care, Device: Right Median Nerve Electrical StimulationConventional treatment combined with right median nerve electrical stimulation. |
Who may qualify
- Ages
- 20 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Neurosurgical and Supportive CareRoutine 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. | Other | Conventional Treatment + Median Nerve Electrical Stimulation, Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy |
| Right Median Nerve Electrical StimulationThe 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 | Conventional Treatment + Median Nerve Electrical Stimulation, Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy |
| Auricular Press-Needle TherapyDisposable 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. | Device | Conventional Treatment + Median Nerve Electrical Stimulation + Auricular Press-Needle Therapy |
Primary outcome
Awakening Rate of Patients with Consciousness Disorder After Traumatic Brain Injury (TBI)
Time frame: 8 weeks after the start of the intervention (which is the end of the full intervention course for the study).
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.
1 secondary outcome
Change in Glasgow Coma Scale (GCS) Score
Time frame: Baseline (pre-intervention), 4 weeks, 6 weeks, 8 weeks post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 42209901Li H, Song W, Zeng S, Liu L, Liu C, Lu H. Promoting Consciousness Recovery in Patients with Acquired Brain Injury Through Multimodal Sensory Stimulation: A Randomized Controlled Trial of Median Nerve and Auricular Stimulation. Neurocrit Care. 2026 May 28. doi: 10.1007/s12028-026-02543-x. Online ahead of print.
- Individual participant dataSharing planned: No. Patient Privacy Protection: Collected IPD includes sensitive personal health information. Per China's Personal Information Protection Law and hospital ethical requirements, sharing IPD risks unauthorized disclosure, violating patients' information security rights. Informed Consent Limitations : Participants' signed consent only authorizes IPD use for this study's research goals, not sharing with external parties. Without additional ethical approval and patient re-consent, sharing is non-compliant with ethical commitments. Data Security \& Integrity : IPD is managed under The First Affiliated Hospital of Gannan Medical University's security system. External sharing may cause data tampering, improper use, or loss, compromising result integrity and analysis credibility. Future IPD sharing (e.g., collaborative research) will require hospital Ethics Committee approval, patient re-consent, and strict de-identification/transfer protocols to meet legal and ethical standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hai N Li, Middle Initia study chair
First Affiliated Hospital of Gannan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Neurosurgical and Supportive Care, Right Median Nerve Electrical Stimulation and Auricular Press-Needle Therapy in people with Traumatic Brain Injury and Cerebral Hemorrhage, run by Li Hai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awakening Rate of Patients with Consciousness Disorder After Traumatic Brain Injury (TBI) (time frame: 8 weeks after the start of the intervention (which is the end of the full intervention course for the study).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07273864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.