Cerebellar iTBS in Patients With Disorders of Consciousness

Disorder of Consciousness Clinical Trial

— CTPDOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558930
• Other study ID #: 20222028
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: October 2023

Study information

• Verified date: May 2022
• Source: Xijing Hospital
• Contact: Rong Chen
• Phone: 18292575563
• Email: cmuchenrong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

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.
• sham stimulation
Participants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field

Locations

Country	Name	City	State
China	Xijing hospital, Air Force Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CRS-R Total Scores	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).	Baseline and directly after 5 sessions of iTBS and sham stimulation(5 days)
Secondary	Change in CRS-R Subscale Scores	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).	Baseline and directly after 5 sessions of iTBS and sham stimulation(5 days)
Secondary	Change of Influence on EEG	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.	Baseline and after 5 sessions of iTBS and sham stimulation(5 days)
Secondary	Influence of time since insult on the results	Glasgow Outcome Scale-Extended(GOSE) score will be assessed at 3 and 6 months of enrollment.	Participants will be followed for the duration of 0.5 year