Cerebellar iTBS in Patients With Disorders of Consciousness (CTPDOC)

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Vegetative State; Minimally Conscious State; Disorder of Consciousness

Treatments: Device: iTBS stimulation; Device: sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05558930

20222028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

iTBS stimulation

Experimental group

Description:

Participants receive iTBS stimulation of bilateral cerebellar one session per day for 5 consecutive days.

Treatment:

Device: iTBS stimulation

sham stimulation

Sham Comparator group

Description:

Participants receive sham stimulation of bilateral cerebellar one session per day for 5 consecutive days.

Treatment:

Device: sham stimulation