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pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke

Primary Purpose

Stroke, Ischemic, Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active continuous Theta Burst Stimulation
sham continuous Theta Burst Stimulation
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: Patients between the ages of 35 and 75 years (including 35 and 75 years). Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association 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 and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months . Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8. First onset stroke. Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education). Understand the trial and be able to provide informed consent. Exclusion Criteria: Combined severe dysarthria (NIHSS item 10 score ≥ 2 points); Aphasia caused by bilateral hemispheric stroke, brain tumors, 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; Patients with severe systemic diseases such as heart, lung, liver, kidney diseases, etc., which cannot be controlled by routine medications as confirmed by laboratory tests and examinations; Impaired consciousness (NIHSS item 1(a) score ≥ 1 point); Malignant hypertension; Malignant tumor; Patients with a life expectancy of less than 1 year due to reasons other than stroke; Severe hearing, visual, or cognitive impairments that prevent the patient from completing the trial; Patients with severe depression, anxiety, or other mental illnesses that prevent them from completing the trial; Patients who have received other neuroregulatory treatments such as TMS or transcranial electrical stimulation within 3 months before enrollment; History of alcohol abuse, drug abuse, or other substance abuse; Patients with other abnormal test results that make them unsuitable for participating in this trial as determined by the researchers; Women of childbearing age who are pregnant or planning to become pregnant; Patients participating in other clinical trials.

Sites / Locations

  • First Affiliated Hospital of Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active cTBS group

sham cTBS group

Arm Description

active cTBS combined with speech language therapy

sham cTBS 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 into an Aphasia Quotient, lower scores indicate worse outcomes.

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 into an Aphasia Quotient, lower scores indicate worse outcomes.
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 1 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
June 8, 2023
Last Updated
September 4, 2023
Sponsor
Changping Laboratory
Collaborators
First Affiliated Hospital of Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05907031
Brief Title
pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke
Official Title
Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy Targeting at the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changping Laboratory
Collaborators
First Affiliated Hospital of Fujian Medical University

4. Oversight

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

5. Study Description

Brief Summary
The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery 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, investigators 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 rTMS intervention in post-stroke aphasic patients. Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS) group, or a sham control 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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active cTBS group
Arm Type
Active Comparator
Arm Description
active cTBS combined with speech language therapy
Arm Title
sham cTBS group
Arm Type
Sham Comparator
Arm Description
sham cTBS combined with speech language therapy
Intervention Type
Device
Intervention Name(s)
active continuous Theta Burst Stimulation
Intervention Description
Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive days each week.
Intervention Type
Device
Intervention Name(s)
sham continuous Theta Burst Stimulation
Intervention Description
Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive days each week.
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 into an Aphasia Quotient, lower scores indicate worse outcomes.
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 into an Aphasia Quotient, lower scores indicate worse outcomes.
Time Frame
baseline, end of the 5-day therapy, end of the follow-up of 3 weeks
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 1 to level 5, with lower scores indicating more severe aphasia.
Time Frame
baseline,end of the 3-week therapy,end of the follow-up of 3 weeks
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,end of the follow-up of 3 weeks

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: Patients between the ages of 35 and 75 years (including 35 and 75 years). Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association 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 and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months . Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8. First onset stroke. Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education). Understand the trial and be able to provide informed consent. Exclusion Criteria: Combined severe dysarthria (NIHSS item 10 score ≥ 2 points); Aphasia caused by bilateral hemispheric stroke, brain tumors, 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; Patients with severe systemic diseases such as heart, lung, liver, kidney diseases, etc., which cannot be controlled by routine medications as confirmed by laboratory tests and examinations; Impaired consciousness (NIHSS item 1(a) score ≥ 1 point); Malignant hypertension; Malignant tumor; Patients with a life expectancy of less than 1 year due to reasons other than stroke; Severe hearing, visual, or cognitive impairments that prevent the patient from completing the trial; Patients with severe depression, anxiety, or other mental illnesses that prevent them from completing the trial; Patients who have received other neuroregulatory treatments such as TMS or transcranial electrical stimulation within 3 months before enrollment; History of alcohol abuse, drug abuse, or other substance abuse; Patients with other abnormal test results that make them unsuitable for participating in this trial as determined by the researchers; Women of childbearing age who are pregnant or planning to become pregnant; Patients participating in other clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianting Huang, MD,PhD
Phone
010-80726688
Email
jianting.huang@pku.edu.cn
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, PhD
Organizational Affiliation
Changping Laboratory
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Yu

12. IPD Sharing Statement

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pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke

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