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Noninvasive neuroregulation of the whole cycle of consciousness impairment rehabilitation based on multimodal images

Noninvasive neuroregulation of the whole cycle of consciousness impairment rehabilitation based on multimodal images

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109503
Enrollment
Unknown
Registered
2025-09-19
Start date
2025-09-19
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consciousness Impairment

Interventions

control group:Conventional rehabilitation treatment and drug-induced awakening treatment (including amantadine, zolpidem, angong Niuhuang Pills, etc.).
light group:The light therapy group received light therapy on the basis of conventional rehabilitation. :810nm0.9W/cm243.2J/cm2. :40Hz,50%,1200(20). :20,1/,10. :40Hz50%1200s810nmW=0.9 W/cm2×,. :((DLPF
TI group:The TI treatment group received TI treatment on the basis of routine rehabilitation. Scheme: Low intensity stimulation 4mA, twice a day for 2 hours (9:00-11:00 am, 15:00-17:00 PM), continuous
light+TI group:The light + TI treatment group received light and TI combined treatment on the basis of conventional rehabilitation treatment. The specific protocol was the same as above, and the inte

Sponsors

Ankang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Consciousness impairment caused by various reasons such as traumatic brain injury, cerebral hemorrhage, cerebral infarction, and hypoxic-ischemic encephalopathy, with a coma lasting more than 14 days, and the degree of consciousness impairment is assessed as minimally conscious state; 2. Age between 18 and 65 years; 3. Stable vital signs and no severe complications; 4. Family informed and consented.

Exclusion criteria

Exclusion criteria: 1. Patients with intracranial metallic implants or cardiac pacemakers, or those contraindicated for MRI examinations; 2. Individuals with organic brain disorders, prior traumatic brain injuries, or surgical histories; 3. Participants with documented mental health conditions, neurological disorders, or substance abuse that may compromise study efficacy assessment as determined by investigators; 4. Pregnant or breastfeeding women; 5. Patients experiencing uncontrollable frequent seizures following trauma; 6. Those with contraindications to transcranial magnetic stimulation (TMS) or transcranial near-infrared light therapy (NIR); 7. Patients who have received phototherapy or other physical interventions (e.g., transcranial magnetic stimulation, transcranial electrical stimulation, etc.) within the past 30 days; 8. Inability to provide informed consent; 9. Other circumstances deemed unsuitable for study intervention by investigators.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale-Revised(CRS-R);Full Outline of UnResponsiveness(FOUR);

Secondary

MeasureTime frame
electroencephalogram (EEG);evoked potential; multimoding MRI;PET-CT;

Countries

China

Contacts

Public ContactDongbo Li

Ankang Central Hospital

lidongbo1103@sina.com+86 138 9150 9609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026