Cerebellar iTBS in Patients With Disorders of Consciousness

NCT05558930 | Unknown

• 1 other identifier: 20222028
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness; Vegetative State; Minimally Conscious State

Keywords

TMS; cerebellar; iTBS; DOC; MCS; VS

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）

Secondary Outcomes (3)

• Change in CRS-R Subscale Scores

  Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）

• Change of Influence on EEG

  Baseline and after 5 sessions of iTBS and sham stimulation（5 days）

• Influence of time since insult on the results

  Participants will be followed for the duration of 0.5 year

Study Arms (2)

iTBS stimulation

EXPERIMENTAL

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

Device: iTBS stimulation

sham stimulation

SHAM COMPARATOR

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

Device: sham stimulation

Interventions

iTBS stimulation DEVICE

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.

iTBS stimulation

sham stimulation DEVICE

Participants receive a sound stimulation with the same pattern with iTBS stimulation,but without magnetic field

sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VS/UWS or MCS according to diagnostic criteria
• Age ≥18 years
• Written informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital, Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness

Central Study Contacts

Rong Chen

CONTACT

18292575563; cmuchenrong@126.com

Wen Jiang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 28, 2022
• Study Start: April 29, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-05

Locations

CN (1)