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

Stroke, Ischemic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907031
• Other study ID #: CPSA02FJ30
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: Changping Laboratory
• Contact: Jianting Huang, MD,PhD
• Phone: 010-80726688
• Email: jianting.huang[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Device:
• active continuous Theta Burst Stimulation
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.
• sham continuous Theta Burst Stimulation
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Changping Laboratory	First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, end of the 3-week therapy
Secondary	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.	baseline, end of the 5-day therapy, end of the follow-up of 3 weeks
Secondary	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.	baseline,end of the 3-week therapy,end of the follow-up of 3 weeks
Secondary	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.	baseline,end of the 3-week therapy,end of the follow-up of 3 weeks