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 range18 Years – 80 Years
SexALL
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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
✕. 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;
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