pBFS-guided iTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke

NCT ID: NCT05929534

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-06-30

Brief Summary

The objective of this trial is to evaluate the effectiveness and safeness of intermittent Theta Burst Stimulation (iTBS) over the left Superior Temporal Gyrus (STG), 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 Sector (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 sham controlled 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 intermittent TBS (iTBS) group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol consists 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 iTBS group

active iTBS combined with speech language therapy

Group Type: ACTIVE_COMPARATOR

active intermittent Theta Burst Stimulation

Intervention Type: DEVICE

Each patient will receive two 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.

sham iTBS group

sham iTBS combined with speech language therapy

Group Type: SHAM_COMPARATOR

sham intermittent Theta Burst Stimulation

Intervention Type: DEVICE

Each patient will receive two sham 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.

Interventions

active intermittent Theta Burst Stimulation

Each patient will receive two 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.

Intervention Type: DEVICE

sham intermittent Theta Burst Stimulation

Each patient will receive two sham 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.

Intervention Type: DEVICE

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 acute ischemic stroke (diagnosed according to the "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" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, and a duration of ≥15 days and ≤3 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 severe 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 objects, 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.

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

Sponsors

Changping Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hesheng Liu, PhD

Role: STUDY_CHAIR

Changping Laboratory

Central Contacts

Na Xu, PhD

Role: CONTACT

naxu@cpl.ac.cn

010-80726688

Other Identifiers

CPSA04HLJ40

Identifier Type: -

Identifier Source: org_study_id