Cerebellar iTBS in Patients With Disorders of Consciousness (CTPDOC)

September 25, 2022 updated by: Xijing Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing hospital, Air force Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and directly after 5 sessions of iTBS and sham stimulation（5 days）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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）
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.
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
Glasgow Outcome Scale-Extended(GOSE) score will be assessed at 3 and 6 months of enrollment.
Participants will be followed for the duration of 0.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2022

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 25, 2022

First Posted (ACTUAL)

September 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20222028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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