MRI-navigated Cerebellar Intermittent Theta-Burst Stimulation（iTBS）in Patients With Disorders of Consciousness
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Disorder of Consciousness
- Sponsor
- Xijing Hospital
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change in CRS-R Total Scores
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •VS/UWS or MCS according to diagnostic criteria
- •Age ≥18 years
- •Written informed consent obtained
Exclusion Criteria
- •Patients in coma
- •Brain injury \<1week
- •Presence of metallic hardware in close contact to the discharging coil（such as cochlear implants, or an Internal Pulse Generator or medication pumps）
- •Patients with high risks according to standard questionnaire to screen transcranial magnetic stimulation(TMS) candidates
Outcomes
Primary Outcomes
Change in CRS-R Total Scores
Time Frame: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）
Whether bilateral cerebellar iTBS would improve consciousness in enrolled patients. CRS-R total score is used to measure level of consciousness of disorder.The coma recovery scale-revised(CRS-R) consists of six subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.The lowest item on each subscale represents reflexive activity and the highest item represents cognitively mediated behavior. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).The score for each subscale is based on the presence or absence of a specific behavioral response to a sensory stimulus (higher scores are better).
Secondary Outcomes
- Influence of time since insult on the results(Participants will be followed for the duration of 0.5 year)
- Change of Influence on EEG(Baseline and after 5 sessions of iTBS and sham stimulation（5 days）)
- Change in CRS-R Subscale Scores(Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）)