Using brain stimulation to improve language recovery in stroke patients with aphasia

Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy Targeting at Superior Temporal Gyrus for Aphasia After Ischemic Stroke: a RCT

This study is testing whether a special brain stimulation technique can help stroke patients with language difficulties recover their speech better than a placebo treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Changping Laboratory (other)
• Locations: 2 sites (Changchun and 1 other locations)
• Trial ID: NCT05999318 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of continuous Theta Burst Stimulation (cTBS) over the right Superior Temporal Gyrus, guided by personalized Brain Function Sector (pBFS) technology, for language recovery in patients with post-ischemic stroke aphasia. The study employs a double-blinded, randomized, and parallel controlled design, where participants are assigned to either an active cTBS group or a sham control group. The treatment consists of a 3-week regimen with 15 sessions of stimulation, utilizing real-time neuronavigation to ensure precision in targeting the individualized stimulation site based on resting-state functional MRI data.

Who should consider this trial

Good fit: Ideal candidates are Chinese-speaking adults aged 35 to 75 who have experienced their first ischemic stroke and have been diagnosed with aphasia.

Not a fit: Patients who do not meet the inclusion criteria, such as those with prior strokes or other neurological conditions affecting language, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance language recovery in patients suffering from aphasia after a stroke.

How similar studies have performed: Previous studies have shown promise in using rTMS for treating post-stroke symptoms, suggesting potential success for this novel approach.

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, 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 bodies, 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.

Where this trial is running

Changchun and 1 other locations

• First Hospital of Jilin University — Changchun, China (RECRUITING)
• Shengjing Hospital of China Medical University — Shenyang, China (RECRUITING)

Study contacts

• Study coordinator: Na Xu, PhD

Conditions: Stroke, Ischemic, Aphasia