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

NCT ID: NCT05907031

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2025-12-30

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.

Conditions

Stroke, Ischemic; Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active cTBS group

active cTBS combined with speech language therapy

Group Type: ACTIVE_COMPARATOR

active continuous Theta Burst Stimulation

Intervention Type: DEVICE

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 cTBS group

sham cTBS combined with speech language therapy

Group Type: SHAM_COMPARATOR

sham continuous Theta Burst Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Changping Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hesheng Liu, PhD

Role: STUDY_CHAIR

Changping Laboratory

Locations

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianting Huang, MD,PhD

Role: CONTACT

jianting.huang@pku.edu.cn

010-80726688

Ruiqi Pan

Role: CONTACT

ruiqipanedu@163.com

010-80726688

Facility Contacts

Jun Yu

Role: primary

Other Identifiers

CPSA02FJ30

Identifier Type: -

Identifier Source: org_study_id