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The awakening effect of neuromodulation technology on patients with disorders of consciousness: a multi-center, double blind, randomized controlled clinical trial

The awakening effect of neuromodulation technology on patients with disorders of consciousness: a multi-center, double blind, randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043784
Enrollment
Unknown
Registered
2021-02-28
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-28

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

Conditions

Disorders of Consciousness

Interventions

Median nerve stimulation group:Median nerve electrical stimulation (MNS)
Transcranial direct current stimulation group:Transcranial direct current stimulation (tDCS)
Median nerve electrical stimulation + transcranial magnetic stimulation group:MNS+TMS
Median nerve electrical stimulation + transcranial direct current stimulation group:MNS+tDCS
Control group:Conventional rehabilitation

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Craniocerebral injury is the main pathogenic factor and confirmed by CT and (or) MRI of the brain, accompanied by disturbance of consciousness, and craniocerebral injury is the only pathogenic factor; 3. Course of DOC>= 28 days; 4. DOC is assessed by Glasgow coma scale (GCS) ( 2 points or vision> 1 point or sports > 2 points or speech response > 2 points or communication > 0 points or arousal > 2 points) by CRS-R; 5. Stable vital signs; 6. The patients' family members are informed and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with critical illness and unstable vital signs; 2. Active cerebral hemorrhage; 3. Patients with metal objects in the brain; 4. Pacemakers in the body; 5. Unconsciousness caused by other reasons; 6. Past history of epilepsy or family history of epilepsy; 7. Severe heart, liver, kidney and other vital organ failure; 8. Pregnancy.

Design outcomes

Primary

MeasureTime frame
GCS;CRS-R;full outline of unresponsiveness (FOUR);

Secondary

MeasureTime frame
evoked potentials;electroencephalogram;CT perfusion;adverse event;

Countries

China

Contacts

Public ContactFeng Zhen

The First Affiliated Hospital of Nanchang University

fengzhenly@sina.com+86 13970038111

Outcome results

None listed

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