The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injecti… (NCT06927336) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury
China200 participantsStarted 2025-04-25
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
electroencephalogram
Timeframe: From enrollment to the end of treatment at 2 weeks
2
Oxygenated hemoglobin concentration (HbO)
Timeframe: From enrollment to the end of treatment at 2 weeks
Trial details
NCT IDNCT06927336
SponsorThe Second Affiliated Hospital of Kunming Medical University
. 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.