Skip to content

Effectiveness of transcranial magnetic stimulation on awaking patients with disorders of consciousness: a randomized controlled trial

Effectiveness of transcranial magnetic stimulation on awaking patients with disorders of consciousness: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044930
Enrollment
Unknown
Registered
2021-03-31
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-02

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

Conditions

disorders of consciousness

Interventions

Treatment group:Transcranial magnetic stimulation therapy, conventional medication therapy, rehabilitation therapy
Control group:Conventional medication therapy, rehabilitation therapy

Sponsors

Department of Rehabilitation Medicine, the First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients over 18 years old; 2.Patients whose disease interval is more than 1 month and less than 1 year; 3.Based on the Coma Recovery Scale-revised (CRS-R) and GCS scale scores, patients diagnosed as mimimally conscious state, vegetative state and coma, and no serious brain stem lesions were found; 4.Patients with stable vital signs; 5.All hemorrhage lesions in patients with cerebral hemorrhage are completely absorbed; 6.Conduct CRS-R evaluation every other day within a week, and the score is stable in the same interval; 7.Patient's family members agree the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patient who has a history of epilepsy;patient's first-degree relatives have a history of idiopathic epilepsy and the use of epileptic drugs; EEG shows epileptiform discharge; 2.Patients with hypoxic-ischemic encephalopathy; 3.There is a shunt in the patient's brain; 4.There is an implantable cardiac pacemaker, cardiac catheter or electronic pump in the patient's heart; 5.There is a metal aneurysm clip in the patient's brain; 6.There are metal nails or vascular suture devices in the patient's brain; 7.There are neurostimulators or brain/subdural electrodes in the patient's brain; 8.Patients who use metal plates to close the skull defect at the TMS stimulation site; 9.Patients with extensive skin damage; 10.Patients with complications such as acute myocardial infarction, pulmonary embolism, acute infection, sepsis, severe anemia, etc.; 11.Patients with other serious systemic diseases or clinical critical conditions (respiratory or hemodynamic instability).

Design outcomes

Primary

MeasureTime frame
The score of the Coma Recovery Scale-Revised;

Secondary

MeasureTime frame
The score of the Glasgow coma sacle;The score of the Chinese vegetative state scale;The score of the Clinical global impression-improvement;Quantitative EEG power analysis;Motor evoked potential;Brainstem auditory evoked potential;Somatosensory evoked potential;Occurrence of adverse events;

Countries

China

Contacts

Public ContactLu Xiao

Department of Rehabilitation Medicine, the First Affiliated Hospital of Nanjing Medical University

luxiao1972@163.com+86 13813958023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026