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Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT

Primary Purpose

Stroke, Ischemic, Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active cTBS
sham cTBS
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 2 months and less than or equal to 1 year . 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, or with a history of stroke without apparent sequelae ( scored≤1 on modified Rankin Scale score (mRS) before the current 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: Patients with comorbid severe dysarthria (NIHSS item 10 dysarthria ≥ 2). Aphasia caused by other diseases such as brain tumor, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, traumatic brain injury, etc. Patients with MRI scan and TMS treatment contraindications, such as claustrophobia, cardiac pacemaker, cochlear implant or other metallic foreign body and any electronic device implanted in the body. History of epilepsy (having at least 2 uninduced seizures more than 24h apart, or a diagnosis of epilepsy syndrome, or having seizures within the past 12 months). Patients with severe combined cardiac, pulmonary, hepatic, renal and other systemic diseases that cannot be controlled by conventional medication. Patients with comorbid disorders of consciousness ( NIHSS 1(a)≥1). Patients with combined malignant hypertension (sudden and significant increase in blood pressure, with increased systolic and diastolic blood pressure, often persisting above 200/130 mmHg) Patients with co-malignant neoplasm. Patients with a life expectancy of less than 1 year due to causes other than stroke. Patients with combined deafness, visual impairment, or severe cognitive impairment to the extent that they are unable to cooperate with the test. Patients with severe depression, anxiety, or diagnosed with other mental disorders to the extent that they are unable to cooperate with the trial. History of TMS, transcranial electrical stimulation and other neuromodulation treatments in the past 3 months. History of alcohol, drug, and/or other abuse. Patients with other test abnormalities judged by the investigator to be unsuitable for the trial. Women of childbearing age who are pregnant or preparing for pregnancy. Patients who are participating in other clinical research trials.

Sites / Locations

  • China Rehabilitation Research CenterRecruiting

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 conventional rehabilitation therapy

Sham cTBS combined with conventional rehabilitation 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.
National Institute of Health stroke scale
The 11-item National Institutes of Health Stroke Scale (NIHSS) will be used to evaluate participants' degree of neural deficits after stroke. Each item is associated with a specific ability, each scores between 0 to 4. The individual scores will be summed to calculate a participant's total NIHSS score. The total possible score is between 0 to 42, higher scores indicate worse outcomes.

Full Information

First Posted
April 24, 2023
Last Updated
June 9, 2023
Sponsor
Changping Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT05842304
Brief Title
Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT
Official Title
Personalized Brain Functional Sectors (pBFS)-Guided rTMS Intervention for Aphasia After Ischemic Stroke: a Multi-center, Randomized, Parallel Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
May 10, 2024 (Anticipated)
Study Completion Date
May 10, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic 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, 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 multi-center, double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized TMS 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 2:1. Subjects will receive a 3-week treatment for 21 consecutive days. 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
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active cTBS group
Arm Type
Active Comparator
Arm Description
active cTBS combined with conventional rehabilitation therapy
Arm Title
sham cTBS group
Arm Type
Sham Comparator
Arm Description
Sham cTBS combined with conventional rehabilitation therapy
Intervention Type
Device
Intervention Name(s)
active cTBS
Intervention Description
Each patient will receive three 600-pulse cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks).
Intervention Type
Device
Intervention Name(s)
sham cTBS
Intervention Description
Each patient will receive three 600-pulse sham cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 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 into an Aphasia Quotient, lower scores indicate worse outcomes.
Time Frame
baseline, end of the 21-day 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 7-day therapy, end of the follow-up of 3 weeks
Title
National Institute of Health stroke scale
Description
The 11-item National Institutes of Health Stroke Scale (NIHSS) will be used to evaluate participants' degree of neural deficits after stroke. Each item is associated with a specific ability, each scores between 0 to 4. The individual scores will be summed to calculate a participant's total NIHSS score. The total possible score is between 0 to 42, higher scores indicate worse outcomes.
Time Frame
baseline, end of the 21-day therapy

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 2 months and less than or equal to 1 year . 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, or with a history of stroke without apparent sequelae ( scored≤1 on modified Rankin Scale score (mRS) before the current 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: Patients with comorbid severe dysarthria (NIHSS item 10 dysarthria ≥ 2). Aphasia caused by other diseases such as brain tumor, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, traumatic brain injury, etc. Patients with MRI scan and TMS treatment contraindications, such as claustrophobia, cardiac pacemaker, cochlear implant or other metallic foreign body and any electronic device implanted in the body. History of epilepsy (having at least 2 uninduced seizures more than 24h apart, or a diagnosis of epilepsy syndrome, or having seizures within the past 12 months). Patients with severe combined cardiac, pulmonary, hepatic, renal and other systemic diseases that cannot be controlled by conventional medication. Patients with comorbid disorders of consciousness ( NIHSS 1(a)≥1). Patients with combined malignant hypertension (sudden and significant increase in blood pressure, with increased systolic and diastolic blood pressure, often persisting above 200/130 mmHg) Patients with co-malignant neoplasm. Patients with a life expectancy of less than 1 year due to causes other than stroke. Patients with combined deafness, visual impairment, or severe cognitive impairment to the extent that they are unable to cooperate with the test. Patients with severe depression, anxiety, or diagnosed with other mental disorders to the extent that they are unable to cooperate with the trial. History of TMS, transcranial electrical stimulation and other neuromodulation treatments in the past 3 months. History of alcohol, drug, and/or other abuse. Patients with other test abnormalities judged by the investigator to be unsuitable for the trial. Women of childbearing age who are pregnant or preparing for pregnancy. Patients who are participating in other clinical research 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
Facility Information:
Facility Name
China Rehabilitation Research Center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Zhang, MD,PhD

12. IPD Sharing Statement

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Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT

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