Back to resultspBFS-guided Multi-target cTBS for Aphasia After Stroke
Primary Purpose
Stroke, Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active continuous Theta Burst Stimulation
sham continuous Theta Burst Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
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 ischemic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2019 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2018) or meet the diagnostic criteria for hemorrhagic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2022 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2019) ，with lesions located in the left hemisphere, and a duration of illness ranging from 15 days to 6 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 language function before the onset of stroke, and the patient's native language is Chinese with at least 6 years of education; Understand the trial and signed the informed consent form. Exclusion Criteria: Combined 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 neuromodulation 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
- Affiliated Hospital of Hebei UniversityRecruiting
- Affiliated Hospital of Chengde Medical UniversityRecruiting
- Hebei General HospitalRecruiting
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 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.
Token test
The Token Test is a language assessment tool used to evaluate a person's ability to understand spoken language and follow instructions. Each correct response in each task is awarded one point, typically. Different point values may be assigned based on the complexity of the task. The total score is calculated by adding up the accumulated scores across all tasks. The total scores range from 0 to 36, with higher scores indicating better language abilities.
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
1. Study Identification
Unique Protocol Identification Number
NCT05957445
Brief Title
pBFS-guided Multi-target cTBS for Aphasia After Stroke
Official Title
Personalized Brain Functional Sector-guided Multi-target Continuous Theta Burst Stimulation Therapy for Aphasia After 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
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 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
In this study, a randomized, double-blind, parallel-controlled trial was employed to evaluate the effectiveness and safety of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) and the superior frontal gyrus (SFG) for language function recovery in post-stroke aphasic patients.
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 multi-target 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 5 consecutive workdays 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, Aphasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (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 a series of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, and subsequently a 600-pulse cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.
Intervention Type
Device
Intervention Name(s)
sham continuous Theta Burst Stimulation
Intervention Description
Each patient will receive a series of stimulation sequences，including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, and subsequently a 600-pulse sham cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays 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 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
Token test
Description
The Token Test is a language assessment tool used to evaluate a person's ability to understand spoken language and follow instructions. Each correct response in each task is awarded one point, typically. Different point values may be assigned based on the complexity of the task. The total score is calculated by adding up the accumulated scores across all tasks. The total scores range from 0 to 36, with higher scores indicating better language abilities.
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 ischemic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2019 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2018) or meet the diagnostic criteria for hemorrhagic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2022 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2019) ，with lesions located in the left hemisphere, and a duration of illness ranging from 15 days to 6 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 language function before the onset of stroke, and the patient's native language is Chinese with at least 6 years of education;
Understand the trial and signed the informed consent form.
Exclusion Criteria:
Combined 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 neuromodulation 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
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
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xincai Yang
Facility Name
Affiliated Hospital of Chengde Medical University
City
Chengde
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijie Gou
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Yin
12. IPD Sharing Statement
Learn more about this trial
pBFS-guided Multi-target cTBS for Aphasia After Stroke
We'll reach out to this number within 24 hrs