NCT05558930

Cerebellar iTBS in Patients With Disorders of Consciousness

MRI-navigated Cerebellar Intermittent Theta-Burst Stimulation（iTBS）in Patients With Disorders of Consciousness

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Disorder of Consciousness
• Vegetative State
• Minimally Conscious State

Interventions

Type	Name	Description
DEVICE	iTBS stimulation	standard iTBS burst pattern:3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals. 600 pulses on both side of cerebellar with an interval of 5 minutes.
DEVICE	sham stimulation	Participants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field

Timeline

• Start date: 2022-04-29
• Primary completion: 2023-04-01
• Completion: 2023-10-01
• First posted: 2022-09-28
• Last updated: 2022-09-28

Locations

1 site across 1 country: China