Disorder of ConsciousnessCTPDOCNCT05558930
Cerebellar iTBS in Patients With Disorders of Consciousness
A study testing iTBS stimulation in people with Disorder of Consciousness and Vegetative State, run by Xijing Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness, Vegetative State, Minimally Conscious State
- What is being tested?
- iTBS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VS/UWS or MCS according to diagnostic criteria
- Age ≥18 years
- Written informed consent obtained
Who cannot join
- Patients in coma
- Brain injury <1week
- Presence of metallic hardware in close contact to the discharging coil（such as cochlear implants, or an Internal Pulse Generator or medication pumps）
- Patients with high risks according to standard questionnaire to screen transcranial magnetic stimulation(TMS) candidates
Trial locations and contacts
1 site in 1 country.
Wen Jiang contact
China1 site, 1 recruiting
- Recruiting
Xijing hospital, Air Force Military Medical University
Xi'an, Shaanxi, 710032
Rong Chen, 18292575563, cmuchenrong@126.com
About this study
Official title: MRI-navigated Cerebellar Intermittent Theta-Burst Stimulation（iTBS）in Patients With Disorders of Consciousness
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.
Read the 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.
- Being tested
- iTBS stimulation, sham stimulation
- Keywords
- TMS, cerebellar, iTBS, DOC, MCS, VS
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS stimulationDevice
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 stimulationDevice
Participants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field
| Study group | Role | What they receive |
|---|---|---|
| iTBS stimulation | Experimental | Participants receive iTBS stimulation of bilateral cerebellar one session per day for 5 consecutive days. Receives: Device: iTBS stimulation |
| sham stimulation | Sham comparator | Participants receive sham stimulation of bilateral cerebellar one session per day for 5 consecutive days. Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Participants will be followed for the duration of 0.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start29 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558930
- Sponsor's protocol ID
- 20222028
- Acronym
- CTPDOC
- Status last verified
- May 2022
- First submitted
- 1 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-navigated Cerebellar Intermittent Theta-Burst Stimulation（iTBS）in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT05558930
- Acronym / sponsor ID
- CTPDOC / 20222028
- Keywords
- TMS, cerebellar, iTBS, DOC, MCS, VS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| iTBS stimulation | Experimental | Device: iTBS stimulationParticipants receive iTBS stimulation of bilateral cerebellar one session per day for 5 consecutive days. |
| sham stimulation | Sham comparator | Device: sham stimulationParticipants receive sham stimulation of bilateral cerebellar one session per day for 5 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- VS/UWS or MCS according to diagnostic criteria
- Age ≥18 years
- Written informed consent obtained
Key exclusion criteria (4 listed)
- Patients in coma
- Brain injury <1week
- Presence of metallic hardware in close contact to the discharging coil（such as cochlear implants, or an Internal Pulse Generator or medication pumps）
- Patients with high risks according to standard questionnaire to screen transcranial magnetic stimulation(TMS) candidates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTBS stimulationstandard 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. | Device | iTBS stimulation |
| sham stimulationParticipants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field | Device | sham stimulation |
Primary outcome
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).
3 secondary outcomes
Change in CRS-R Subscale Scores
Time frame: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）
Change of Influence on EEG
Time frame: Baseline and after 5 sessions of iTBS and sham stimulation（5 days）
Influence of time since insult on the results
Time frame: Participants will be followed for the duration of 0.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Related trials for Disorder of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Jiang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS stimulation in people with Disorder of Consciousness and Vegetative State, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Chen (18292575563, cmuchenrong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CRS-R Total Scores (time frame: Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.