An interventional study of iTBS stimulation and sham stimulation in Disorder of Consciousness, Vegetative State and Minimally Conscious State, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
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.
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.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 44 is close to the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive iTBS stimulation of bilateral cerebellar one session per day for 5 consecutive days.
Device: iTBS stimulation
Participants receive sham stimulation of bilateral cerebellar one session per day for 5 consecutive days.
Device: sham 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.
Participants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field
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).
Time frame: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）
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).
Time frame: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）
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.
Time frame: Baseline and after 5 sessions of iTBS and sham stimulation（5 days）
Influence of time since insult on the results
Glasgow Outcome Scale-Extended(GOSE) score will be assessed at 3 and 6 months of enrollment.
Time frame: Participants will be followed for the duration of 0.5 year
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.