Personalized brain stimulation for language recovery after stroke

Personalized Brain Functional Sector-guided Dual-target Continuous Theta Burst Stimulation Therapy for Aphasia After Stroke: a RCT

This study is testing a new type of brain stimulation to see if it can help people recover their language skills after having a stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 2 sites (Jinan, Shandong and 1 other locations)
• Trial ID: NCT05957354 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on specific brain areas to aid language recovery in patients who have suffered a stroke. It employs a double-blinded, randomized, and parallel controlled design, where participants are assigned to either an active treatment group or a sham control group. The treatment involves a 3-week regimen of stimulation, utilizing real-time neuronavigation to ensure precision in targeting the brain regions involved in language function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35 to 75 who have experienced their first ischemic or hemorrhagic stroke affecting the left hemisphere and have been diagnosed with aphasia.

Not a fit: Patients who do not meet the age or stroke criteria, 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 enhance language recovery in post-stroke aphasic patients.

How similar studies have performed: Other studies have shown promise in using rTMS for stroke recovery, but the specific application of pBFS-guided dual-target stimulation is relatively novel.

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 ischemic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2019 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2018) or meet the diagnostic criteria for hemorrhagic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2022 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2019) ，with lesions located in the left hemisphere, and a duration of illness ranging from 15 days to 6 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 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

Jinan, Shandong and 1 other locations

• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Ruiqi Pan

Conditions Stroke; Aphasia