Clinical trial NCT05558930: Cerebellar iTBS in Patients With Disorders of Consciousness
Official title: MRI-navigated Cerebellar Intermittent Theta-Burst Stimulation（iTBS）in Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder of Consciousness
Vegetative State
Minimally Conscious State
Keywords: TMS
cerebellar
iTBS
DOC
MCS
VS
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized double-blinded, sham-controlled, crossover study design is used to investigate the effects of bilateral cerebellar iTBS on patients with prolonged DOC in a VS/UWS or in a MCS state. We prospectively recruit 44 patients in VS/UWS or MCS state. Each patient will receive bilateral cerebellar iTBS and sham stimulation in random order, one session per day for 5 consecutive days, separated by a 5-day washout. TMS is performed by personalized neuro-navigation to target the cerebellar dentate nucleus. The primary research outcome is whether bilateral cerebellar iTBS, as compared to sham stimulation, will improve consciousness (as measured by changes in CRS-R total scores) in VS/UWS and MCS patients. Secondary research outcome is evaluated by Electroencephalogram(EEG), CRS-R subscore, and Glasgow Outcome Scale-Extended(GOSE) score at 3 and 6 months of enrollment.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in CRS-R Total Scores
timeFrame: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）
Secondary outcomes:
measure: Change in CRS-R Subscale Scores
timeFrame: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）
measure: Change of Influence on EEG
timeFrame: Baseline and after 5 sessions of iTBS and sham stimulation（5 days）
measure: Influence of time since insult on the results
timeFrame: Participants will be followed for the duration of 0.5 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital, Air Force Military Medical University
state: Shaanxi
Study officials:
References: