Disorders of Consciousness
Conditions
Interventions
Control group:Conventional rehabilitation therapy and pharmacological arousal therapy
Temporal interference stimulation (TI) group:Upon completion of the first treatment course, a 10-day interval will be observed. The decision to proceed with a second treatment course will be based on
Sponsors
Ankang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Disorder of consciousness (DoC) caused by various reasons such as brain trauma, cerebral hemorrhage, cerebral infarction, hypoxic-ischemic encephalopathy, etc., with a coma duration of more than 14 days, and the degree of DoC is evaluated as minimally conscious state; 2. Age between 18 and 65 years; 3. Stable vital signs without serious complications; 4. Legal representatives are informed and consented to participate.
Exclusion criteria
Exclusion criteria: 1. Presence of intracranial metallic implants or cardiac pacemakers, or any other contraindication to magnetic resonance imaging (MRI); 2. Prior history of structural brain disease, traumatic brain injury or brain surgery; 3. History of psychiatric disorders, neurological disorders, or substance abuse, which in the judgement of investigator may affect the assessment of intervention efficacy; 4. Pregnant or breastfeeding women; 5. Presence of uncontrollable frequent seizures following injury; 6. Presence of contraindications to tTIS; 7. Received other cranial physiotherapy (e.g., transcranial magnetic stimulation, transcranial electrical stimulation) within the past 30 days; 8. Inability to obtain informed consent; 9. Other conditions that the investigators consider unsuitable for the study intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coma Recovery Scale-Revised Score;Full Outline of UnResponsiveness Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glasgow Coma Scale Score;Glasgow Outlook Scale-Extended Score;Disability Rating Scale;Electroencephalography data;Multimodal magnetic resonance image;Routine blood examination;Cytokines and inflammatory mediators;Neurobiological Biomarkers;Pain Visual Analogue Scale Score;Headache Impact Test-6;Pain Catastrophizing Scale Score;Digit Span Test;Wechsler Memory Scale - Logical Memory subtest score;Digit Symbol Coding;Beck Anxiety Inventory;Beck Depression Inventory Score;Post-traumatic Stress Disorder Checklist for DSM-5 Score;Montreal Cognitive Assessment Score;Trail Making Test A/B; | — |
Countries
China
Contacts
Public ContactFeng Liu
Ankang Central Hospital
Outcome results
None listed