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tDCS and rTMS in Patients With Early Disorders of Consciousness

Primary Purpose

Disorder of Consciousness, Stroke, Ischemic-hypoxic Encephalopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tDCS
rTMS
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Consciousness focused on measuring Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 18-80 years diagnosis of stroke or ischemic-hypoxic encephalopathy confirmed by neuroimaging (head MRI) DOC, Glasgow coma score (GCS) <12 4.2-4 weeks of DOC 5.informed consent obtained from the patient's legal representative. Exclusion Criteria: foreign bodies such as metal or electronic devices in the skull (inside or on the surface of the tissue at the treatment stimulation site) pacemaker or cochlear implants history of epilepsy and family history of epilepsy large cranial defects significant cerebral edema lesions in both DLPFC pregnant women with severe physical diseases such as heart, lung, liver and kidney brain death new intracerebral lesions in patients during the study period affecting the assessment and prognosis, e.g. new stroke

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    tDCS treatment group

    rTMS treatment group

    conventional treatment group

    Arm Description

    On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.

    On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.

    Not receiving any neuromodulation treatment.

    Outcomes

    Primary Outcome Measures

    CRS-R
    The unabbreviated scale title is the coma recovery scale-revised.The CRS-R tests six components: auditory, language, visual, communication, motor and arousal levels, with a total score of 0-23. The lower the score, the more severe the brain damage and the deeper the DOC level.

    Secondary Outcome Measures

    GCS
    The unabbreviated scale title is Glasgow coma score. The GCS tested 3 components: eye opening response, verbal response and motor response, with a total score of 15. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
    FOUR
    The unabbreviated scale title is full outline of unresponsiveness. The FOUR tested 4 components: eye opening response, brainstem reflex, respiratory pattern and motor response, with a total score of 0-16. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
    MMN
    The unabbreviated scale title is mismatch negative, representing an important component of auditory event-related potentials. We measure the occurrence, latency and wave amplitude of MMN.
    MEP
    The unabbreviated scale title is motor evoked potential, which can examine the overall synchronization and integrity of the motor nerve transmission and conduction pathways from the cortex to the muscle. We measure the occurrence, latency and wave amplitude of MEP.
    ABCD model of neural oscillation
    The total frequency content of the EEG is represented by a power spectrum that indicates the neural oscillations at different frequencies within the EEG signal. the ABCD model roughly classifies these changes in the EEG power spectrum into four types of ABCD, and this model is thought to reflect the severity of thalamo-cortical neural afferent block and is used to understand the different degrees of structural and functional afferent impairment present in patients with DOC. The ABCD model can reflect neural oscillations from A to D corresponding to the level of consciousness from DOC to wakefulness.
    brain network transfer entropy
    Information flow between neural networks is the basis for understanding brain signal processing and function. Using the method of transfer entropy to analyze the information flow between two two channels, the wavelet consistency algorithm was applied to reveal the linear and nonlinear correlations between regional local field potentials, and the real-time coupling relationship between two channels of neural signals in time-frequency space, including coupling strength and coupling direction. Brain network connectivity can be determined, and comatose patients have significantly weaker connectivity than normal whole brain.
    brain network phase synchronization
    The synchronization relationship between two two channels was analyzed using the method of phase synchronization to form a whole-brain synchronization matrix, and the synchronization matrix was calculated to analyze the direction and strength of whole-brain network connectivity by analyzing data such as shortest path and agglomeration coefficient in the small-world network index. Brain network connectivity can be determined, and comatose patients have significantly weaker connectivity than normal whole brain.
    Prognostic scores (mRS)
    The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
    Prognostic scores (GOS)
    The unabbreviated scale title is Glasgow Outcome Scale. GOS includes a score of 1-5, with the higher the score, the better the prognosis.
    Prognostic scores (CRS-R)
    The unabbreviated scale title is the coma recovery scale-revised. The CRS-R includes a total score of 0-23.The lower the score, the worse the prognosis.

    Full Information

    First Posted
    April 7, 2023
    Last Updated
    April 22, 2023
    Sponsor
    Xuanwu Hospital, Beijing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05820178
    Brief Title
    tDCS and rTMS in Patients With Early Disorders of Consciousness
    Official Title
    A Prospective Randomized Controlled Study of the Efficacy of tDCS and rTMS in Promoting Wakefulness in Patients With Early Disorders of Consciousness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2026 (Anticipated)
    Study Completion Date
    April 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xuanwu Hospital, Beijing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder of consciousness (DOC). In order to improve the prognosis of DOC patients with nontraumatic brain injury, we compared the effects of tDCS and rTMS on clinical behavior and neurophysiological performance, and selected a wake-up technique that could improve the prognosis of DOC patients with nontraumatic brain injury as early as possible, so as to reduce the pain of patients and their loved ones, and to reduce the economic burden of society and families.
    Detailed Description
    To study the efficacy of wakefulness promotion in patients with acute DOC due to severe non-traumatic brain injury (including stroke and ischemic-hypoxic encephalopathy), patients with early DOC were randomly divided into conventional treatment group, tDCS treatment group and rTMS treatment group for 14 consecutive days. Clinical scoring, evoked potential assessment, resting-state high-density electroencephalogram(EEG) and TMS-EEG assessment with functional analysis of brain network connectivity were applied for multidimensional assessment of brain function before and after wake-up promotion treatment (day 1 and day 15 of enrollment) to explore non-invasive brain stimulation(NIBS) techniques that can be performed at the bedside - tDCS, rTMS intervention The prognostic follow-up was performed at 3 months, 6 months and 12 months after DOC to compare the awakening rate after tDCS and rTMS prolongation treatment, and to preferably select an effective prolongation technique for early DOC. The safety of tDCS and rTMS was also clarified by comparing the differences in adverse effects and complications between tDCS treatment group and rTMS treatment group and conventional treatment group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorder of Consciousness, Stroke, Ischemic-hypoxic Encephalopathy
    Keywords
    Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tDCS treatment group
    Arm Type
    Experimental
    Arm Description
    On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.
    Arm Title
    rTMS treatment group
    Arm Type
    Experimental
    Arm Description
    On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.
    Arm Title
    conventional treatment group
    Arm Type
    No Intervention
    Arm Description
    Not receiving any neuromodulation treatment.
    Intervention Type
    Device
    Intervention Name(s)
    tDCS
    Intervention Description
    On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.
    Intervention Type
    Device
    Intervention Name(s)
    rTMS
    Intervention Description
    On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.
    Primary Outcome Measure Information:
    Title
    CRS-R
    Description
    The unabbreviated scale title is the coma recovery scale-revised.The CRS-R tests six components: auditory, language, visual, communication, motor and arousal levels, with a total score of 0-23. The lower the score, the more severe the brain damage and the deeper the DOC level.
    Time Frame
    day 15 of enrollment
    Secondary Outcome Measure Information:
    Title
    GCS
    Description
    The unabbreviated scale title is Glasgow coma score. The GCS tested 3 components: eye opening response, verbal response and motor response, with a total score of 15. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
    Time Frame
    day 15 of enrollment
    Title
    FOUR
    Description
    The unabbreviated scale title is full outline of unresponsiveness. The FOUR tested 4 components: eye opening response, brainstem reflex, respiratory pattern and motor response, with a total score of 0-16. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
    Time Frame
    day 15 of enrollment
    Title
    MMN
    Description
    The unabbreviated scale title is mismatch negative, representing an important component of auditory event-related potentials. We measure the occurrence, latency and wave amplitude of MMN.
    Time Frame
    day 15 of enrollment
    Title
    MEP
    Description
    The unabbreviated scale title is motor evoked potential, which can examine the overall synchronization and integrity of the motor nerve transmission and conduction pathways from the cortex to the muscle. We measure the occurrence, latency and wave amplitude of MEP.
    Time Frame
    day 15 of enrollment
    Title
    ABCD model of neural oscillation
    Description
    The total frequency content of the EEG is represented by a power spectrum that indicates the neural oscillations at different frequencies within the EEG signal. the ABCD model roughly classifies these changes in the EEG power spectrum into four types of ABCD, and this model is thought to reflect the severity of thalamo-cortical neural afferent block and is used to understand the different degrees of structural and functional afferent impairment present in patients with DOC. The ABCD model can reflect neural oscillations from A to D corresponding to the level of consciousness from DOC to wakefulness.
    Time Frame
    day 15 of enrollment
    Title
    brain network transfer entropy
    Description
    Information flow between neural networks is the basis for understanding brain signal processing and function. Using the method of transfer entropy to analyze the information flow between two two channels, the wavelet consistency algorithm was applied to reveal the linear and nonlinear correlations between regional local field potentials, and the real-time coupling relationship between two channels of neural signals in time-frequency space, including coupling strength and coupling direction. Brain network connectivity can be determined, and comatose patients have significantly weaker connectivity than normal whole brain.
    Time Frame
    day 15 of enrollment
    Title
    brain network phase synchronization
    Description
    The synchronization relationship between two two channels was analyzed using the method of phase synchronization to form a whole-brain synchronization matrix, and the synchronization matrix was calculated to analyze the direction and strength of whole-brain network connectivity by analyzing data such as shortest path and agglomeration coefficient in the small-world network index. Brain network connectivity can be determined, and comatose patients have significantly weaker connectivity than normal whole brain.
    Time Frame
    day 15 of enrollment
    Title
    Prognostic scores (mRS)
    Description
    The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
    Time Frame
    3 months, 6 months, 12 months after DOC
    Title
    Prognostic scores (GOS)
    Description
    The unabbreviated scale title is Glasgow Outcome Scale. GOS includes a score of 1-5, with the higher the score, the better the prognosis.
    Time Frame
    3 months, 6 months, 12 months after DOC
    Title
    Prognostic scores (CRS-R)
    Description
    The unabbreviated scale title is the coma recovery scale-revised. The CRS-R includes a total score of 0-23.The lower the score, the worse the prognosis.
    Time Frame
    3 months, 6 months, 12 months after DOC

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18-80 years diagnosis of stroke or ischemic-hypoxic encephalopathy confirmed by neuroimaging (head MRI) DOC, Glasgow coma score (GCS) <12 4.2-4 weeks of DOC 5.informed consent obtained from the patient's legal representative. Exclusion Criteria: foreign bodies such as metal or electronic devices in the skull (inside or on the surface of the tissue at the treatment stimulation site) pacemaker or cochlear implants history of epilepsy and family history of epilepsy large cranial defects significant cerebral edema lesions in both DLPFC pregnant women with severe physical diseases such as heart, lung, liver and kidney brain death new intracerebral lesions in patients during the study period affecting the assessment and prognosis, e.g. new stroke
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Zhang, MD
    Phone
    0086-13671376710
    Email
    zhangylq@sina.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    study protocol can be shared.
    IPD Sharing Time Frame
    after Dec 2023, always
    IPD Sharing Access Criteria
    email to authors

    Learn more about this trial

    tDCS and rTMS in Patients With Early Disorders of Consciousness

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