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Cerebellar iTBS in Patients With Disorders of Consciousness (CTPDOC)

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ClinicalTrials.gov Identifier: NCT05558930
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Disorder of Consciousness Vegetative State Minimally Conscious State Device: iTBS stimulation Device: sham stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: MRI-navigated Cerebellar Intermittent Theta-Burst Stimulation（iTBS）in Patients With Disorders of Consciousness
Actual Study Start Date : April 29, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: iTBS stimulation
Participants receive iTBS stimulation of bilateral cerebellar one session per day for 5 consecutive days.
 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 Comparator: sham stimulation
Participants receive sham stimulation of bilateral cerebellar one session per day for 5 consecutive days.
 Device: sham stimulation
Participants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field


Outcome Measures
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Primary Outcome Measures :
  1. Change in CRS-R Total Scores [ Time Frame: 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 :
  1. Change in CRS-R Subscale Scores [ Time Frame: 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).

  2. Change of Influence on EEG [ Time Frame: 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.

  3. Influence of time since insult on the results [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558930


Contacts
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Contact: Rong Chen 18292575563 cmuchenrong@126.com
Contact: Wen Jiang

Locations
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China, Shaanxi
Xijing hospital, Air Force Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Rong Chen    18292575563    cmuchenrong@126.com   
Sponsors and Collaborators
Xijing Hospital
More Information
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT05558930    
Other Study ID Numbers: 20222028
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
TMS
cerebellar
iTBS
 DOC
MCS
VS
Additional relevant MeSH terms:
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Consciousness Disorders
Persistent Vegetative State
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Unconsciousness