The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Second Affiliated Hospital of Kunming Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • XinNaoJing injection
  • tDCS

Treatment groups

200 Participants
are divided into 3 treatment groups