Cerebellar iTBS in Patients With Disorders of Consciousness

Not Applicable

• Conditions: Disorder of Consciousness; Minimally Conscious State; Vegetative State
• Interventions: Device: iTBS stimulation; Device: sham stimulation

• 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.

Study Timeline

• Study Start: 2022-04-29
• Status Verified: 2022-05
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-25
• Last Update Submitted: 2022-09-25
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-04
• Study Completion: 2023-10

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

Arm && Interventions

Group	Intervention	Description
iTBS stimulation	iTBS stimulation	Participants receive iTBS stimulation of bilateral cerebellar one session per day for 5 consecutive days.
sham stimulation	sham stimulation	Participants receive sham stimulation of bilateral cerebellar one session per day for 5 consecutive days.

Primary Outcome Measures

Name	Time	Method
Change in CRS-R Total Scores	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 Outcome Measures

Name	Time	Method
Influence of time since insult on the results	Participants 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 EEG	Baseline 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 Scores	Baseline 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