Cerebellar iTBS in Patients With Disorders of Consciousness
NCT ID: NCT05558930
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2022-04-29
2023-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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iTBS stimulation
Participants receive iTBS stimulation of bilateral cerebellar one session per day for 5 consecutive days.
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 sham stimulation of bilateral cerebellar one session per day for 5 consecutive days.
sham stimulation
Participants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years
3. Written informed consent obtained
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Locations
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Xijing hospital, Air Force Military Medical University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Wen Jiang
Role: CONTACT
Facility Contacts
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Other Identifiers
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20222028
Identifier Type: -
Identifier Source: org_study_id
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