Personalized rTMS treatment for language recovery after stroke

Personalized Brain Functional Sectors (pBFS)-Guided rTMS Intervention for Aphasia After Ischemic Stroke: a Multi-center, Randomized, Parallel Controlled Study

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

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05842304 on ClinicalTrials.gov

What this trial studies

This multi-center trial evaluates the efficacy and safety of personalized brain functional sectors (pBFS)-guided repetitive transcranial magnetic stimulation (rTMS) for language rehabilitation in patients with aphasia following ischemic stroke. Participants will be randomly assigned to receive either active continuous theta burst stimulation (cTBS) or a sham control treatment over a period of three weeks. The study employs a double-blinded, randomized, and parallel controlled design, utilizing resting-state functional MRI data to identify individualized stimulation sites for optimal treatment. The aim is to improve language functions in post-stroke patients through targeted neuromodulation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35 to 75 who have experienced an acute ischemic stroke with aphasia and meet specific diagnostic criteria.

Not a fit: Patients with strokes affecting areas outside the left hemisphere or those with severe pre-existing language impairments may not benefit from this study.

Why it matters

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

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

Eligibility criteria

Inclusion Criteria:

1. Patients between the ages of 35 and 75 years (including 35 and 75 years).
2. 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 2 months and less than or equal to 1 year .
3. 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.
4. First onset, or with a history of stroke without apparent sequelae ( scored≤1 on modified Rankin Scale score (mRS) before the current stroke).
5. 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).
6. Understand the trial and be able to provide informed consent.

Exclusion Criteria:

1. Patients with comorbid severe dysarthria (NIHSS item 10 dysarthria ≥ 2).
2. Aphasia caused by other diseases such as brain tumor, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, traumatic brain injury, etc.
3. Patients with MRI scan and TMS treatment contraindications, such as claustrophobia, cardiac pacemaker, cochlear implant or other metallic foreign body and any electronic device implanted in the body.
4. History of epilepsy (having at least 2 uninduced seizures more than 24h apart, or a diagnosis of epilepsy syndrome, or having seizures within the past 12 months).
5. Patients with severe combined cardiac, pulmonary, hepatic, renal and other systemic diseases that cannot be controlled by conventional medication.
6. Patients with comorbid disorders of consciousness ( NIHSS 1(a)≥1).
7. Patients with combined malignant hypertension (sudden and significant increase in blood pressure, with increased systolic and diastolic blood pressure, often persisting above 200/130 mmHg)
8. Patients with co-malignant neoplasm.
9. Patients with a life expectancy of less than 1 year due to causes other than stroke.
10. Patients with combined deafness, visual impairment, or severe cognitive impairment to the extent that they are unable to cooperate with the test.
11. Patients with severe depression, anxiety, or diagnosed with other mental disorders to the extent that they are unable to cooperate with the trial.
12. History of TMS, transcranial electrical stimulation and other neuromodulation treatments in the past 3 months.
13. History of alcohol, drug, and/or other abuse.
14. Patients with other test abnormalities judged by the investigator to be unsuitable for the trial.
15. Women of childbearing age who are pregnant or preparing for pregnancy.
16. Patients who are participating in other clinical research trials.

Where this trial is running

Beijing

• China Rehabilitation Research Center — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Ruiqi Pan

Conditions Stroke, Ischemic; Aphasia