Different treatment methods for early disorders of consciousness

ISRCTN	ISRCTN15236545
DOI	https://doi.org/10.1186/ISRCTN15236545
Sponsor	Second Hospital of Hebei Medical University
Funder	Investigator initiated and funded

Submission date: 01/06/2026
Registration date: 17/06/2026
Last edited: 15/06/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Long Zhao
Public, Scientific, Principal investigator

The Second Hospital of Hebei Medical University
Shijiazhuang
050000
China

Phone	+86 (0)311-87046901
Email	zhaoll2658zz@126.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment
Scientific title	Treatment of early consciousness disorders
Study objectives
Ethics approval(s)	Approved 10/03/2025, The Second Hospital of Hebei Medical University (No. 215, Heping West Road, Xinhua District, Shijiazhuang, 050000, China; -; pub@hb2h.com), ref: 2025-C023
Health condition(s) or problem(s) studied	Early disorders of consciousness
Intervention	The random sequence was generated by SPSS 24.0 software. The patients were divided into 4 groups according to the enrollment ratio of 1:1:1:1. The treatment period is two weeks. A follow-up visit will be conducted one year after the treatment. 1. Transcranial direct current stimulation group (conventional treatment + tDCS): conventional treatment combined with transcranial direct current stimulation (tDCS) 2. Transcranial electrical stimulation group (conventional treatment + tACS): conventional treatment combined with transcranial alternating current stimulation (tACS) 3. Transcranial pulsed electrical stimulation group (conventional treatment + tPCS): conventional treatment combined with transcranial pulse current stimulation (tPCS) 4. Control group (conventional treatment): 4.1. Clinical symptomatic treatment: measures such as dehydration to reduce intracranial pressure, nerve nutrition, anti-infection treatment, nutritional support treatment, and regulation of water, electrolyte, and acid-base balance. 4.2. Regular rehabilitation treatments include: 4.2.1. Lower limb intelligent rehabilitation training 4.2.2. Neuromuscular electrical stimulation 4.2.3. Multiple sensory stimulation 4.2.4. Stimulation of the cerebellar paraflocculus region 4.2.5. Electrical stimulation of the median nerve
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Transcranial electrical stimulation device
Primary outcome measure(s)	The degree of the patient's coma measured using the Glasgow Coma Scale (GCS), comprising three items: eye-opening response (E, up to 4 points), verbal response (V, up to 5 points), and motor response (M, up to 6 points), at within 24 hours after enrollment and after 2 weeks of treatment Neurobehavioral function measured using the Coma Recovery Scale-Revised (CRS-R) , comprising six sub-items including movement, auditory, speech, vision, communication and arousal level, with scores ranging from 0 to 23 points, at within 24 hours after enrollment and after 2 weeks of treatment Electrical activity in the brain measured using electroencephalogram (EEG), comprising 24-channel electrodes placed using the international 10/20 system standard. The grading of consciousness disorders was based on the Synek grading standard of EEG at within 24 hours after enrollment and after 2 weeks of treatment. Pre-attentional processing and sensory memory traces measured using Mismatch Negativity (MMN) (passive Oddball paradigm): the amplitude, latency, and occurrence rate of MMN waves in the frontal-central area at within 24 hours after enrollment and after 2 weeks of treatment Amplitude, latency and occurrence rate of the P3a wave in the superior central area measured using the Medical Event-Related Potential Instrument, Model WJ-1B, at within 24 hours after enrollment and after 2 weeks of treatment
Key secondary outcome measure(s)	Clinical efficacy measured using comprehensive assessment of standardized behavioral scales, neurological functional changes, and functional recovery levels at after 2 weeks of treatment Safety measured using the incidence rates of adverse events such as epileptic seizures, local skin burns, arrhythmias, cardiac arrest, hemodynamic changes, decreased oxygen saturation, removal of tracheal intubation or internal tubes, and worsening of the condition in patients at after 2 weeks of treatment
Completion date	31/12/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	152
Key inclusion criteria	1. Patients with consciousness disorders caused by traumatic brain injury, ischemic hypoxic encephalopathy and cerebrovascular diseases 2. All are first-time cases, with a disease course within 28 days 3. Age between 18 and 80 years old 4. The patients' families are informed, voluntarily participate and sign the informed consent form
Key exclusion criteria	1. Patients with critical condition and unstable vital signs/unstable mental state (showing signs of spontaneous recovery or deterioration within 1 week) 2. Patients with severe arrhythmia or those with implanted cardiac pacemakers 3. Patients with metal objects in the brain 4. Patients with active intracranial hemorrhage 5. Patients with a history of epilepsy or a family history of epilepsy 6. Patients with skull defects at the stimulation site, those who have undergone skull metal material repair, or those with local infection
Date of first enrolment	01/04/2025
Date of final enrolment	31/03/2027

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

15/06/2026: Study’s existence confirmed by the Research Ethics Committee of the Second Hospital of Hebei Medical University, China.