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

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

This study is testing if a special brain stimulation technique can help stroke patients with language problems recover their speaking abilities better than a placebo treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05907031 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus, guided by personalized Brain Functional Sector (pBFS) technology, to enhance language function recovery in patients suffering from aphasia after an ischemic stroke. 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 spans three weeks, with five sessions each week, utilizing real-time neuronavigation for precise stimulation targeting based on individual brain functional networks identified through resting-state functional MRI data.

Who should consider this trial

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

Not a fit: Patients with strokes occurring less than 15 days ago or those with pre-existing language impairments prior to the stroke may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve language recovery in stroke patients with aphasia, enhancing their quality of life.

How similar studies have performed: Previous studies have shown promising results using rTMS for post-stroke rehabilitation, suggesting potential success for this novel approach.

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.

Where this trial is running

Fuzhou, Fujian

• First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Jianting Huang, MD,PhD

Conditions Stroke, Ischemic; Aphasia