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MRI-navigated Cerebellar Intermittent Theta-Burst Stimulation(iTBS)in Patients With Disorders of Consciousness
Previous studies showed the excitatory effect of cerebellar transcranial magnetic stimulation(TMS) on motor cortex.Investigator evaluate the effects of bilateral cerebellar TMS on Coma Recovery Scale-Revised (CRS-R) scores in patients with disorders of consciousness(DOC) in a randomized, double-blinded, sham-controlled, crossover experimental design.
Patients with disorders of consciousness(DOC) resulting from severe brain injury greatly burden caregivers, health care facilities, and society. However, there is no definitively effective treatment for patients with DOC. Previous studies showed the excitatory effect of cerebellar transcranial magnetic stimulation(TMS) on motor cortex through the dentato-rubro-thalamic tract. Investigators aim to validate the effect of 5 consecutive sessions of intermittent theta-burst stimulation(iTBS) of bilateral cerebellar on level of consciousness of patients in vegetative state(VS)/unresponsive awakening state(UWS)or minimally conscious (MCS) state in a randomized, double-blinded, sham-controlled, crossover study. TMS is a non-invasive and safe neural regulatory approach that is widely used in depression, schizophrenia, stroke, and Parkinson's disease.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Xijing hospital, Air Force Military Medical University
Xi'an, Shaanxi, China
Start Date
April 29, 2022
Primary Completion Date
April 1, 2023
Completion Date
October 1, 2023
Last Updated
September 28, 2022
44
ESTIMATED participants
iTBS stimulation
DEVICE
sham stimulation
DEVICE
Wen Jiang
CONTACT
Lead Sponsor
Xijing Hospital
NCT06931665
NCT05706831
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View ClinicalTrials.gov Terms and ConditionsNCT05285124