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Key Technologies and System Development of Evaluation and Early Warning of Elderly Consciousness/Cognitive Impairment and Multi physical Factor Collaborative Stimulation Intervention: A Randomized and Controlled Clinical Study of Central Combined Peripheral Nerve Regulation Technology for the Treatment of Consciousness Impairment

Key Technologies and System Development of Evaluation and Early Warning of Elderly Consciousness/Cognitive Impairment and Multi physical Factor Collaborative Stimulation Intervention: A Randomized and Controlled Clinical Study of Central Combined Peripheral Nerve Regulation Technology for the Treatment of Consciousness Impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092089
Enrollment
Unknown
Registered
2024-11-08
Start date
2023-12-02
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Disorders of consciousness

Interventions

Group A: Conventional treatment group:none
Group B: tDCS group:Transcranial direct current stimulation (tDCS)
Group C: MNS combined with tDCS group:Median nerve electrical stimulation (MNS) combined with transcranial direct current stimulation (tDCS)

Sponsors

The Third Affiliated Hospital of Sun Yat sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1Age = 18 years old; 2 Consciousness disorders caused by trauma, stroke, or hypoxia; 3 The course of the disease is = 2 weeks; 4 Diagnosed as vegetative state (VS/UWS) or MCS based on clinical diagnostic criteria and CRS-R; 5 Stable vital signs and no progressive neurological symptoms; 6 If using consciousness improvement drugs for at least 2 weeks or more, no dose adjustment will be made during the enrollment period; 7 Voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1Previous history of brain tumor, traumatic brain injury, epilepsy (or EEG indicating epileptic like changes), or mental disorders History; 2 Consciousness disorders present before stroke; 3 Skull defect, intracranial hypertension, intracranial infection; 4 Metal or electronic device implants (such as pacemakers, cochlear implants, deep brain stimulators, dynamic,Pulse tumor clip, internal fixation device after entriculoperitoneal shunt surgery, etc); 5 Unstable heart disease, high blood pressure; 6 Other serious diseases that may affect the study

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale - Revised Score;Awakening rate;

Secondary

MeasureTime frame
Glass Coma Scale Score;Glasgow Outcome Score;Resting electroencephalogram;Event related potential;

Countries

China

Contacts

Public ContactXiquan Hu

The Third Affiliated Hospital of Sun Yat sen University

huxiquan@mail.sysu.edu.cn+86 189 2210 2910

Outcome results

None listed

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