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The study on the efficacy and mechanism of temporal interference stimulation in improving consciousness in children with chronic disorders of consciousness.

The study on the efficacy and mechanism of temporal interference stimulation in improving consciousness in children with chronic disorders of consciousness.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090858
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

prolonged disorders of consciousness

Interventions

Experimental group:Target localization is performed through MRI imaging and simulation algorithms. The product conducts multiple high-frequency sinusoidal pulse currents (2.00kHz and 2.01kHz) of diffe
Control group:The control group received sham stimulation, with aThe control group received sham stimulation, with a0 minutes per session on each with a treatment frequency of 20 minutes per session o

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: ? Age > 2 years old, 28 days; ? The level of consciousness disorder is assessed as VS or MCS by CRS-R scale; ? Vital signs are stable; ? Children's families volunteer to know and sign informed consent.

Exclusion criteria

Exclusion criteria: ? Active cerebral hemorrhage, skull defect; ? Pediatric brain injury is still in a progressive state; ? Epileptic convulsions are not under control; ? There are implantable electronic devices contraindicated by MRI and other imaging techniques; ? Organ failure of liver, kidney and heart.

Design outcomes

Primary

MeasureTime frame
CRS-R;

Secondary

MeasureTime frame
32-lead electroencephalogram;Brain Magnetic Resonance Imaging;Functional Near-Infrared Spectroscopy;Event-Related Potential;Brainstem Auditory Evoked Potential;Visual Evoked Potential;Somatosensory Evoked Potential;

Countries

China

Contacts

Public ContactDengna Zhu

The Third Affiliated Hospital of Zhengzhou University

zhudengna@126.com+86 138 3814 1626

Outcome results

None listed

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