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pBFS-guided cTBS Combined With iTBS Over the Superior Frontal Gyrus for Aphasia After Ischemic Stroke

Primary Purpose

Stroke, Ischemic, Aphasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active cTBS combined with iTBS
sham cTBS combined with iTBS
Sponsored by
Changping Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient's age ranges from 35 to 75 years old (including 35 and 75 years old); Meet the diagnostic criteria for acute ischemic stroke (diagnosed according to the "Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, and a duration of ≥15 days and ≤3 months; Diagnosed as aphasia patient according to the Chinese version of Western Aphasia Battery (WAB), with a WAB-aphasia quotient of less than 93.8 points; First onset of stroke; Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school; Understand the trial and signed the informed consent form. Exclusion Criteria: Combined severe dysarthria (NIHSS item 10 score ≥2 points); Aphasia caused by bilateral hemisphere stroke, brain tumor, traumatic brain injury, Parkinson's disease, motor neuron disease, or other diseases; Patients with implanted electronic devices such as cardiac pacemakers, cochlear implants, or other metal foreign bodies, or those with MRI contraindications such as claustrophobia or TMS treatment contraindications; History of epilepsy; Patient with concomitant severe systemic diseases affecting the heart, lungs, liver, kidneys, etc., and uncontrolled by conventional medication, as detected and confirmed through laboratory testing and examination; Patients with consciousness disorders (NIHSS 1(a) score ≥1); Patients with malignant hypertension; Patients with severe organic diseases, such as malignant tumors, with an expected survival time of less than 1 year; Patients with severe hearing, visual, cognitive impairment or inability to cooperate with the trial; Patients with severe depression, anxiety, or diagnosed with other mental illnesses that prevent them from completing the trial; Patients who have received other neuroregulatory treatments such as TMS, transcranial electric stimulation, etc. in the 3 months prior to enrollment; Patients with a history of alcoholism, drug abuse, or other substance abuse; Patients with other abnormal findings that the researchers judge are not suitable for participation in this trial; Patients who are unable to complete follow-up due to geographical or other reasons; Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial; Patients who are currently participating in other clinical trials.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    active TBS group

    sham TBS group

    Arm Description

    active TBS combined with speech language therapy

    sham TBS combined with speech language therapy

    Outcomes

    Primary Outcome Measures

    Change in the Western Aphasia Battery scores
    The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.

    Secondary Outcome Measures

    Change in the Western Aphasia Battery scores
    The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
    Boston Diagnostic Aphasia Examination Severity Ratings
    The Boston Diagnostic Aphasia Examination (BDAE) Severity Ratings is a clinical tool used to evaluate the severity and type of aphasia in individuals. The assessment includes four domains: communication abilities, language content, speech sound production and response abilities.BDAE severity ratings range from level 0 to level 5, with lower scores indicating more severe aphasia.
    Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
    The SAQOL-39g is a quality of life assessment tool that is used to evaluate the impact of stroke and aphasia on a patient's quality of life. It consists of 39 items that cover a range of domains related to the patient's quality of life, such as communication, physical functioning, mood, and social support. The items are rated on a 5-point Likert scale ranging from "not at all" to "very much", with higher scores indicating better quality of life.

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Changping Laboratory
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06086938
    Brief Title
    pBFS-guided cTBS Combined With iTBS Over the Superior Frontal Gyrus for Aphasia After Ischemic Stroke
    Official Title
    Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Combined With Intermittent Theta Burst Stimulation Therapy Targeting at the Superior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    October 20, 2024 (Anticipated)
    Study Completion Date
    October 20, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changping Laboratory

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The current study aims to evaluate the efficacy and safety of pBFS-guided cTBS combined with iTBS for the rehabilitation of language functions in patients with post-ischemic stroke aphasia.
    Detailed Description
    Increasing evidence suggests that rTMS has been effective in treating various psychological and neurological diseases, including treating post-stroke symptoms. Using the personalized brain functional sectors (pBFS) technique, we could precisely identify individualized brain functional networks and the personalized language-related stimulation site based on the resting-state functional MRI data. The current study proposes to conduct a double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized cTBS combined with iTBS intervention in post-stroke aphasic patients. Subjects will be randomly assigned to the following two groups: active TBS(cTBS+iTBS)group, or a sham TBS(sham cTBS+sham iTBS)group. The allocation ratio will be 1:1. The stimulation protocol consisted of a 3-week treatment, with five consecutive days each week (totally 15 day-treatment) .The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Ischemic, Aphasia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    active TBS group
    Arm Type
    Active Comparator
    Arm Description
    active TBS combined with speech language therapy
    Arm Title
    sham TBS group
    Arm Type
    Sham Comparator
    Arm Description
    sham TBS combined with speech language therapy
    Intervention Type
    Device
    Intervention Name(s)
    active cTBS combined with iTBS
    Intervention Description
    Daily TBS treatment consists of the following combination: active 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + active 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + active 600-pulse cTBS applied to the SFG in the unaffected hemisphere + active 600-pulses iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.
    Intervention Type
    Device
    Intervention Name(s)
    sham cTBS combined with iTBS
    Intervention Description
    Daily sham TBS treatment consists of the following combination: sham 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + sham 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + sham 600-pulse cTBS applied to the SFG in the unaffected hemisphere + 600-pulse sham iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of sham TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.
    Primary Outcome Measure Information:
    Title
    Change in the Western Aphasia Battery scores
    Description
    The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
    Time Frame
    baseline, end of the 3-week therapy
    Secondary Outcome Measure Information:
    Title
    Change in the Western Aphasia Battery scores
    Description
    The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
    Time Frame
    baseline, end of the 5-day therapy, 90 days after treatment initiation
    Title
    Boston Diagnostic Aphasia Examination Severity Ratings
    Description
    The Boston Diagnostic Aphasia Examination (BDAE) Severity Ratings is a clinical tool used to evaluate the severity and type of aphasia in individuals. The assessment includes four domains: communication abilities, language content, speech sound production and response abilities.BDAE severity ratings range from level 0 to level 5, with lower scores indicating more severe aphasia.
    Time Frame
    baseline,end of the 3-week therapy,90 days after treatment initiation
    Title
    Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
    Description
    The SAQOL-39g is a quality of life assessment tool that is used to evaluate the impact of stroke and aphasia on a patient's quality of life. It consists of 39 items that cover a range of domains related to the patient's quality of life, such as communication, physical functioning, mood, and social support. The items are rated on a 5-point Likert scale ranging from "not at all" to "very much", with higher scores indicating better quality of life.
    Time Frame
    baseline,end of the 3-week therapy,90 days after treatment initiation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient's age ranges from 35 to 75 years old (including 35 and 75 years old); Meet the diagnostic criteria for acute ischemic stroke (diagnosed according to the "Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, and a duration of ≥15 days and ≤3 months; Diagnosed as aphasia patient according to the Chinese version of Western Aphasia Battery (WAB), with a WAB-aphasia quotient of less than 93.8 points; First onset of stroke; Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school; Understand the trial and signed the informed consent form. Exclusion Criteria: Combined severe dysarthria (NIHSS item 10 score ≥2 points); Aphasia caused by bilateral hemisphere stroke, brain tumor, traumatic brain injury, Parkinson's disease, motor neuron disease, or other diseases; Patients with implanted electronic devices such as cardiac pacemakers, cochlear implants, or other metal foreign bodies, or those with MRI contraindications such as claustrophobia or TMS treatment contraindications; History of epilepsy; Patient with concomitant severe systemic diseases affecting the heart, lungs, liver, kidneys, etc., and uncontrolled by conventional medication, as detected and confirmed through laboratory testing and examination; Patients with consciousness disorders (NIHSS 1(a) score ≥1); Patients with malignant hypertension; Patients with severe organic diseases, such as malignant tumors, with an expected survival time of less than 1 year; Patients with severe hearing, visual, cognitive impairment or inability to cooperate with the trial; Patients with severe depression, anxiety, or diagnosed with other mental illnesses that prevent them from completing the trial; Patients who have received other neuroregulatory treatments such as TMS, transcranial electric stimulation, etc. in the 3 months prior to enrollment; Patients with a history of alcoholism, drug abuse, or other substance abuse; Patients with other abnormal findings that the researchers judge are not suitable for participation in this trial; Patients who are unable to complete follow-up due to geographical or other reasons; Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial; Patients who are currently participating in other clinical trials.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ruiqi Pan
    Phone
    010-80726688
    Email
    ruiqipanedu@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesheng Liu, Ph.D.
    Organizational Affiliation
    Changping Laboratory
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    pBFS-guided cTBS Combined With iTBS Over the Superior Frontal Gyrus for Aphasia After Ischemic Stroke

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