Personalized brain stimulation for language recovery after stroke

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

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

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Changping Laboratory (other)
• Locations: 3 sites (Baoding, Hebei and 2 other locations)
• Trial ID: NCT05957445 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on specific brain regions to aid language recovery in patients with post-stroke aphasia. It employs a randomized, double-blind, parallel-controlled design, where participants are assigned to either an active cTBS group or a sham control group. The treatment lasts for three weeks, with five sessions each week, utilizing real-time neuronavigation for precise stimulation targeting. The goal is to determine if this tailored approach can improve language function in affected individuals.

Who should consider this trial

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

Not a fit: Patients with a history of prior strokes or those with language function issues prior to their stroke 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: While there is growing evidence supporting rTMS for various neurological conditions, this specific approach using pBFS-guided stimulation is relatively novel and has not been extensively tested.

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

Baoding, Hebei and 2 other locations

• Affiliated Hospital of Hebei University — Baoding, Hebei, China (RECRUITING)
• Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China (RECRUITING)
• Hebei General Hospital — Shijiazhuang, Hebei, China (RECRUITING)

Study contacts

• Study coordinator: Jianting Huang, MD,PhD

Conditions: Stroke, Aphasia