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

Changping Laboratory

Status: Enrolling

Conditions: Stroke, Ischemic; Aphasia

Treatments: Device: active continuous Theta Burst Stimulation; Device: sham continuous Theta Burst Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05907031

CPSA02FJ30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

active cTBS group

Active Comparator group

Description:

active cTBS combined with speech language therapy

Treatment:

Device: active continuous Theta Burst Stimulation

sham cTBS group

Sham Comparator group

Description:

sham cTBS combined with speech language therapy

Treatment:

Device: sham continuous Theta Burst Stimulation