Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT

Last updated: June 17, 2024
Sponsor: Changping Laboratory
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Communication Disorders

Cardiac Ischemia

Treatment

active cTBS

sham cTBS

Clinical Study ID

NCT05842304
CPSA0290
  • Ages 35-75
  • All Genders

Study Summary

The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic stroke aphasic patients.

Eligibility Criteria

Inclusion

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 HeartAssociation/American Stroke Association Guidelines for the Early Management ofPatients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for theEarly Management of Acute Ischemic Stroke and the 2018 Chinese Society of NeurologyGuidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). Alllesions should be in the left hemisphere, and the course of disease should be morethan 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 theWestern 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 onmodified Rankin Scale score (mRS) before the current stroke).

  5. Normal functioning language abilities before the stroke, with Mandarin as theirnative language and an educational level higher than primary school (more than 6years' education).

  6. Understand the trial and be able to provide informed consent.

Exclusion

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, motorneuron 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 anyelectronic device implanted in the body.

  4. History of epilepsy (having at least 2 uninduced seizures more than 24h apart, or adiagnosis of epilepsy syndrome, or having seizures within the past 12 months).

  5. Patients with severe combined cardiac, pulmonary, hepatic, renal and other systemicdiseases 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 inblood pressure, with increased systolic and diastolic blood pressure, oftenpersisting 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 impairmentto the extent that they are unable to cooperate with the test.

  11. Patients with severe depression, anxiety, or diagnosed with other mental disordersto the extent that they are unable to cooperate with the trial.

  12. History of TMS, transcranial electrical stimulation and other neuromodulationtreatments 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 unsuitablefor the trial.

  15. Women of childbearing age who are pregnant or preparing for pregnancy.

  16. Patients who are participating in other clinical research trials.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: active cTBS
Phase:
Study Start date:
June 05, 2023
Estimated Completion Date:
May 10, 2026

Study Description

Increasing evidence suggests that rTMS has been effective in treating various psychological and neurological diseases, including treating post-stroke symptoms. Using the personalized brain functional sectors (pBFS) technique, we could precisely identify individualized brain functional networks and the personalized language-related stimulation site based on the resting-state functional MRI data. The current study proposes to conduct a multi-center, double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized TMS intervention in post-stroke aphasic patients.

Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS) group, or a sham control group. The allocation ratio will be 2:1. Subjects will receive a 3-week treatment for 21 consecutive days. The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.

Connect with a study center

  • China Rehabilitation Research Center

    Beijing,
    China

    Active - Recruiting

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