tDCSPhase 4NCT06927336
The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury
A Phase 4 study testing XinNaoJing injection and tDCS in people with tDCS and Cerebellum, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- tDCS, Cerebellum, Brain Injury
- What is being tested?
- XinNaoJing injection and tDCS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-80 years;
- All patients met the diagnostic criteria of DoC;
- more than 1 month after the initial head injury;
- stable consciousness for at least 2 weeks before admission (no change in CRS-R total score);
- no skull defect or large area of skull repair;
- The legal representative authorized by the patient approved the experimental protocol and signed the informed consent form.
Who cannot join
- supratentorial abnormalities on computed tomography (CT) or magnetic resonance imaging (MRI) involving more than one third of the middle cerebral artery territory;
- a life expectancy of less than 3 months or a follow-up of less than 3 months;
- retention of intracranial metal objects, cranial debridement, or presence of cranial defects and any clinically significant or unstable medical diseases;
- EEG recording with significant muscle artifacts and inhibitory bursts;
- nonconvulsive status epilepticus; Periodic or burst rhythms evoked by stimulation;
- disturbance of consciousness due to surgical injury or tumor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Electroencephalography
Kunming, Yunnan
Yao, +8613529202383, yaoliqing98731@163.com
About this study
The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used as objective indicators to distinguish VS from MCS. (2) To clarify the changes of consciousness level and brain function in DoC patients with craniocerebral injury treated with tDCS stimulation of cerebellum combined with Xingnaojing.
- Conditions
- tDCS, Cerebellum, Brain Injury, Disturbance of Consciousness
- Being tested
- XinNaoJing injection, tDCS
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XinNaoJing injectionDrug
XingNaoJing injection is a kind of traditional Chinese medicine preparation, which has the effects of clearing heat and detoxifying, cooling blood and activating blood circulation, resuscitating the brain. In recent years, it has been often used in the treatment of related symptoms caused by qi and blood disturbance and cerebral blood stasis, and has achieved certain results. Xingnaojing injection contains Yujin to resuscitate phlegm, invigorate blood circulation and promote qi; Zhizi dissipates blood stasis and cleans heat; Both are subject medicine. Natural musk cleans the brain, Shujin Tongluo, Jun medicine; Borneol awaken awaken, for adjuvant. Small doses of musk restored brain function and improved cerebral circulation. Xingnaojing injection can promote the recovery of consciousness, reduce the level of plasma β-endorphin, and restore brain function. Borneol bi-dimensionally regulates the central nervous system, calms, prolongs the level of arousal, and protects the brain tissue.
tDCSDevice
tDCS stimulated the cerebellum for 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA.
| Study group | Role | What they receive |
|---|---|---|
| tDCS combined with XingNaoJing treatment group | Experimental | The tDCS stimulation time was 20 minutes, once a day, 5 times a week, a total of 10 times, the stimulation intensity was 2mA, and the stimulation site was the cerebellum. The dosage of Xingnaojing was 20 ml each time by intravenous drip, diluted with 9% sodium chloride injection 200 ml, once a day. Intervention for two weeks. Receives: Drug: XinNaoJing injection; Device: tDCS |
| tDCS treatment group | Sham comparator | The tDCS stimulation time was 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA. Receives: Device: tDCS |
| XingNaoJing treatment group | Sham comparator | The dosage of XingNaoJing was 20 ml each time by intravenous drip, diluted with 9% sodium chloride injection 200 ml, once a day. Receives: Drug: XinNaoJing injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
electroencephalogram
Event-related potential: MMN and P300 in uV; Changes in power spectra and coherence and phase synchronization under delta, theta, and alpha in uV2.
Measured: From enrollment to the end of treatment at 2 weeks
Oxygenated hemoglobin concentration (HbO)
Near-red function test fNRIS: to understand the changes of oxygen saturation in the head. HbO in uM.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (21)
RLA grading Scale
Purpose: Used to assess the level of consciousness in patients after brain injury, especially those in comatose or vegetative states.
Scoring: The scale has 10 levels, each representing different levels of awareness and functioning.
Level 1: No response (Coma) - No response to external stimuli. Level 2: Generalized response - Non-specific responses to stimuli. Level 3: Localized response - Specific responses to stimuli. Level 4: Confused-agitated - Disoriented and agitated behavior. Level 5: Confused-inappropriate - Inappropriate responses to commands, confusion.
Level 6: Confused-appropriate - Appropriate responses but still confused. Level 7: Automatic-appropriate - Performs tasks automatically but still lacks flexibility.
Level 8: Purposeful-appropriate - Independent with a certain level of awareness.
Level 9: Purposeful-appropriate (standby assistance) - Increased independence. Level 10: Purposeful-appropriate (modified independent) - Fully independent.
Measured: From enrollment to the end of treatment at 2 weeks
Glasgow Coma Scale (GCS)
Purpose: Assesses the neurological function and level of consciousness in patients, particularly those in a comatose state.
Scoring: The scale evaluates three components: Eye response (E), Verbal response (V), and Motor response (M). Each component is scored from 1 to 4, and the total score is calculated.
Eye response (E): 4 (spontaneous opening) to 1 (no response). Verbal response (V): 5 (oriented speech) to 1 (no response). Motor response (M): 6 (obeys commands) to 1 (no response). Total score: Ranges from 3 (deep coma) to 15 (fully alert and responsive).
Measured: From enrollment to the end of treatment at 2 weeks
Coma Recovery Scale-Revised (CRS-R)
Purpose: Used to assess recovery in patients with severe brain injuries or in vegetative states.
Scoring: Consists of 23 items evaluating different types of responses such as visual, auditory, and motor responses.
Score range: 0 (no response) to 23 (full recovery). Components: The scale evaluates awareness, attention, perception, language, and motor responses.
Measured: From enrollment to the end of treatment at 2 weeks
FOUR Score (Full Outline of UnResponsiveness)
Purpose: Used to assess the neurological status of patients with impaired consciousness, particularly those unable to communicate verbally.
Scoring: Includes four parameters: Eye response, Brainstem reflexes, Respiratory pattern, and Motor response. Each parameter is scored from 0 to 4.
Eye response: 0 (no response) to 4 (spontaneous eye opening). Brainstem reflexes: 0 (no reflexes) to 4 (normal reflexes). Respiratory pattern: 0 (no breathing) to 4 (spontaneous breathing). Motor response: 0 (no movement) to 4 (voluntary movement). Total score: Ranges from 0 (no response) to 16 (normal response).
Measured: From enrollment to the end of treatment at 2 weeks
Nutritional Risk Screening (NRS 2002)
Purpose: Used to assess the nutritional risk of hospitalized patients. Scoring: The scale includes factors like disease severity, weight loss, and appetite.
Disease severity: 0 (no disease) to 3 (severe disease). Appetite loss: 0 (no loss) to 3 (severe loss of appetite). Weight loss: 0 (no weight loss) to 3 (significant weight loss). Total score: A score of 3 or more indicates moderate to high nutritional risk.
Measured: From enrollment to the end of treatment at 2 weeks
Thrombosis Risk Assessment Scale (Padua Risk Assessment Scale)
Purpose: Used to assess the risk of deep vein thrombosis (DVT) in hospitalized patients.
Scoring: Includes clinical factors like age, obesity, cancer, and bed rest.
Risk score: 0 (low risk) to 3 or more (high risk). Common factors: Advanced age, immobility, surgery, obesity, and malignancy are some factors that increase the risk.
Measured: From enrollment to the end of treatment at 2 weeks
Functional Independence Measure (FIM)
Purpose: Assesses a patient's ability to perform activities of daily living, often used in rehabilitation settings.
Scoring: Includes 13 items assessing daily living tasks (eating, dressing, bathing, toileting) and 5 cognitive tasks (social interaction, problem-solving).
Score range: 1 (total dependence) to 7 (total independence). Total score: The lowest possible score is 18 (completely dependent) and the highest is 126 (completely independent).
Measured: From enrollment to the end of treatment at 2 weeks
Albumin
Albumin in g/L
Measured: From enrollment to the end of treatment at 2 weeks
S100β
S100β in ng/mL
Measured: From enrollment to the end of treatment at 2 weeks
NSE (Neuron-Specific Enolase)
NSE (Neuron-Specific Enolase) in ng/mL
Measured: From enrollment to the end of treatment at 2 weeks
NFL (Neurofilament Light Chain)
NFL (Neurofilament Light Chain) in pg/mL
Measured: From enrollment to the end of treatment at 2 weeks
Tau Protein
Tau Protein in pg/mL
Measured: From enrollment to the end of treatment at 2 weeks
Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1)
Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) in ng/mL
Measured: From enrollment to the end of treatment at 2 weeks
GFAP (Glial Fibrillary Acidic Protein)
GFAP (Glial Fibrillary Acidic Protein) in ng/mL
Measured: From enrollment to the end of treatment at 2 weeks
CK-MB (Creatine Kinase MB Isoform)
CK-MB (Creatine Kinase MB Isoform) in U/L
Measured: From enrollment to the end of treatment at 2 weeks
ALT (Alanine Aminotransferase)
ALT (Alanine Aminotransferase) in U/L
Measured: From enrollment to the end of treatment at 2 weeks
AST (Aspartate Aminotransferase)
AST (Aspartate Aminotransferase) in U/L
Measured: From enrollment to the end of treatment at 2 weeks
Vitamin B12
Vitamin B12 in pg/mL
Measured: From enrollment to the end of treatment at 2 weeks
Thiamine (Vitamin B1)
Thiamine (Vitamin B1) in nmol/L
Measured: From enrollment to the end of treatment at 2 weeks
Vitamin D
Vitamin D in ng/mL
Measured: From enrollment to the end of treatment at 2 weeks
Phosphate
Phosphate in mg/dL.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for tDCSStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liqing Yao, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927336
- Sponsor's protocol ID
- Shen-PJ-Ke-2025-6
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury
- ClinicalTrials.gov ID
- NCT06927336
- Acronym / sponsor ID
- Shen-PJ-Ke-2025-6
- Conditions
- tDCS, Cerebellum, Brain Injury, Disturbance of Consciousness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Apr 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.
The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used as objective indicators to distinguish VS from MCS. (2) To clarify the changes of consciousness level and brain function in DoC patients with craniocerebral injury treated with tDCS stimulation of cerebellum combined with Xingnaojing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS combined with XingNaoJing treatment group | Experimental | Drug: XinNaoJing injection, Device: tDCSThe tDCS stimulation time was 20 minutes, once a day, 5 times a week, a total of 10 times, the stimulation intensity was 2mA, and the stimulation site was the cerebellum. The dosage of Xingnaojing was 20 ml each time by intravenous drip, diluted with 9% sodium chloride injection 200 ml, once a day. Intervention for two weeks. |
| tDCS treatment group | Sham comparator | Device: tDCSThe tDCS stimulation time was 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA. |
| XingNaoJing treatment group | Sham comparator | Drug: XinNaoJing injectionThe dosage of XingNaoJing was 20 ml each time by intravenous drip, diluted with 9% sodium chloride injection 200 ml, once a day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18-80 years;
- All patients met the diagnostic criteria of DoC;
- more than 1 month after the initial head injury;
- stable consciousness for at least 2 weeks before admission (no change in CRS-R total score);
- no skull defect or large area of skull repair;
Key exclusion criteria (6 listed)
- supratentorial abnormalities on computed tomography (CT) or magnetic resonance imaging (MRI) involving more than one third of the middle cerebral artery territory;
- a life expectancy of less than 3 months or a follow-up of less than 3 months;
- retention of intracranial metal objects, cranial debridement, or presence of cranial defects and any clinically significant or unstable medical diseases;
- EEG recording with significant muscle artifacts and inhibitory bursts;
- nonconvulsive status epilepticus; Periodic or burst rhythms evoked by stimulation;
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 |
|---|---|---|
| XinNaoJing injectionXingNaoJing injection is a kind of traditional Chinese medicine preparation, which has the effects of clearing heat and detoxifying, cooling blood and activating blood circulation, resuscitating the brain. In recent years, it has been often used in the treatment of related symptoms caused by qi and blood disturbance and cerebral blood stasis, and has achieved certain results. Xingnaojing injection contains Yujin to resuscitate phlegm, invigorate blood circulation and promote qi; Zhizi dissipates blood stasis and cleans heat; Both are subject medicine. Natural musk cleans the brain, Shujin Tongluo, Jun medicine; Borneol awaken awaken, for adjuvant. Small doses of musk restored brain function and improved cerebral circulation. Xingnaojing injection can promote the recovery of consciousness, reduce the level of plasma β-endorphin, and restore brain function. Borneol bi-dimensionally regulates the central nervous system, calms, prolongs the level of arousal, and protects the brain tissue. | Drug | XingNaoJing treatment group, tDCS combined with XingNaoJing treatment group |
| tDCStDCS stimulated the cerebellum for 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA. | Device | tDCS combined with XingNaoJing treatment group, tDCS treatment group |
Primary outcome
electroencephalogram
Time frame: From enrollment to the end of treatment at 2 weeks
Event-related potential: MMN and P300 in uV; Changes in power spectra and coherence and phase synchronization under delta, theta, and alpha in uV2.
Oxygenated hemoglobin concentration (HbO)
Time frame: From enrollment to the end of treatment at 2 weeks
Near-red function test fNRIS: to understand the changes of oxygen saturation in the head. HbO in uM.
21 secondary outcomes
RLA grading Scale
Time frame: From enrollment to the end of treatment at 2 weeks
Glasgow Coma Scale (GCS)
Time frame: From enrollment to the end of treatment at 2 weeks
Coma Recovery Scale-Revised (CRS-R)
Time frame: From enrollment to the end of treatment at 2 weeks
FOUR Score (Full Outline of UnResponsiveness)
Time frame: From enrollment to the end of treatment at 2 weeks
Nutritional Risk Screening (NRS 2002)
Time frame: From enrollment to the end of treatment at 2 weeks
Thrombosis Risk Assessment Scale (Padua Risk Assessment Scale)
Time frame: From enrollment to the end of treatment at 2 weeks
Functional Independence Measure (FIM)
Time frame: From enrollment to the end of treatment at 2 weeks
Albumin
Time frame: From enrollment to the end of treatment at 2 weeks
S100β
Time frame: From enrollment to the end of treatment at 2 weeks
NSE (Neuron-Specific Enolase)
Time frame: From enrollment to the end of treatment at 2 weeks
NFL (Neurofilament Light Chain)
Time frame: From enrollment to the end of treatment at 2 weeks
Tau Protein
Time frame: From enrollment to the end of treatment at 2 weeks
Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1)
Time frame: From enrollment to the end of treatment at 2 weeks
GFAP (Glial Fibrillary Acidic Protein)
Time frame: From enrollment to the end of treatment at 2 weeks
CK-MB (Creatine Kinase MB Isoform)
Time frame: From enrollment to the end of treatment at 2 weeks
ALT (Alanine Aminotransferase)
Time frame: From enrollment to the end of treatment at 2 weeks
AST (Aspartate Aminotransferase)
Time frame: From enrollment to the end of treatment at 2 weeks
Vitamin B12
Time frame: From enrollment to the end of treatment at 2 weeks
Thiamine (Vitamin B1)
Time frame: From enrollment to the end of treatment at 2 weeks
Vitamin D
Time frame: From enrollment to the end of treatment at 2 weeks
Phosphate
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XinNaoJing injection and tDCS in people with tDCS and Cerebellum, run by The Second Affiliated Hospital of Kunming Medical University 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 6 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: opening soon, as of the sponsor's last update on 15 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liqing Yao (+8613529202383, yaoliqing98731@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electroencephalogram (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.