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The therapeutic effect of intermittent burst theta wave stimulation of the cerebellum on the disorders of consciousness after craniocerebral injury and its brain mechanism

The therapeutic effect of intermittent burst theta wave stimulation of the cerebellum on the disorders of consciousness after craniocerebral injury and its brain mechanism

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078365
Enrollment
Unknown
Registered
2023-12-06
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Disorders of consciousness after craniocerebral injury

Interventions

Observational studies-Intervention group:NA
Observational studies-Control group:NA
Intervention study-intervention group:The 100f transcranial magnetic stimulator and "8" wire from Nanjing Weisi were used for iTBS. The iTBS treatment was performed with a 100f transcranial magnetic s
the iTBS stimulation intensity was 75% of the resting motor threshold
the basic frequency of iTBS mode was 5Hz. The basic frequency of iTBS mode was 5 Hz, and 1 short burst of stimulation was given every 200 ms, in which 3 individual pulses at 50 Hz were buried in each
iTBS was administered to both sides of the cerebellum separately with a 5-minute interval. The iTBS treatment was carried out separately on both sides of the cerebellum with an interval of 5 minutes
iTBS treatment was carried out once a day, 5 times a week, for 4 weeks.
Intervention study-control group:The only difference between the intervention and control iTBS treatment groups is the orientation of the "8" coil: In the intervention group, the "8" coil was aligned

Sponsors

The First Affiliated Hospital of Gannan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: ? Age = 18 years, regardless of gender; ?stable condition within 1 month of onset; ?Primary illness was craniocerebral trauma, stroke or ischemic-hypoxic encephalopathy; ? presence of DOC, meeting the international diagnostic criteria of UWS/VS and MCS; ? Immediate family members of the patient agreed to participate in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria: ? No CNS disease other than the primary disease; ?Current use of central excitatory or sedative drugs; ? having recent seizures or being on anti-epileptic drugs; ?have other serious medical conditions with a life expectancy of less than 3 months; ? have a contraindication to MRI or are unable to cooperate in completing an MRI; ? Contraindication to iTBS therapy or inability to cooperate with completion of iTBS therapy; ? Patients who do not comply with follow-up or have poor compliance.

Design outcomes

Primary

MeasureTime frame
rs-fMRI examination;

Secondary

MeasureTime frame
CRS-R Score;Electroencephalogram examination and analysis;

Countries

China

Contacts

Public ContactLuo Yun

The First Affiliated Hospital of Gannan Medical University

735083566@qq.com+86 157 5430 6145

Outcome results

None listed

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