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Cerebellar iTBS in Patients With Disorders of Consciousness

Not Applicable
Conditions
Disorder of Consciousness
Minimally Conscious State
Vegetative State
Registration Number
NCT05558930
Lead Sponsor
Xijing Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
44
Inclusion Criteria
  1. VS/UWS or MCS according to diagnostic criteria
  2. Age ≥18 years
  3. Written informed consent obtained
Exclusion Criteria
  1. Patients in coma
  2. Brain injury <1week
  3. Presence of metallic hardware in close contact to the discharging coil(such as cochlear implants, or an Internal Pulse Generator or medication pumps)
  4. Patients with high risks according to standard questionnaire to screen transcranial magnetic stimulation(TMS) candidates

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Change in CRS-R Total ScoresBaseline 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 Outcome Measures
NameTimeMethod
Influence of time since insult on the resultsParticipants will be followed for the duration of 0.5 year

Glasgow Outcome Scale-Extended(GOSE) score will be assessed at 3 and 6 months of enrollment.

Change of Influence on EEGBaseline and after 5 sessions of iTBS and sham stimulation(5 days)

EEG will be monitored on the first and fifth sessions of both iTBS and sham stimulation, from 20 minutes before the start of stimulation until 30 minutes after the end of stimulation.

Change in CRS-R Subscale ScoresBaseline and directly after 5 sessions of iTBS and sham stimulation(5 days)

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. 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).

Trial Locations

Locations (1)

Xijing hospital, Air Force Military Medical University

🇨🇳

Xi'an, Shaanxi, China

Xijing hospital, Air Force Military Medical University
🇨🇳Xi'an, Shaanxi, China
Rong Chen
Contact
18292575563
cmuchenrong@126.com

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