pBFS-guided cTBS at Different Doses for Aphasia After Stroke

Last updated: April 2, 2025
Sponsor: Changping Laboratory
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Communication Disorders

Treatment

active 2400-pulse continuous Theta Burst Stimulation

active 1200-pulse continuous Theta Burst Stimulation

active 3600-pulse continuous Theta Burst Stimulation

Clinical Study ID

NCT05969548
CPSA08HN60
  • Ages 35-75
  • All Genders

Study Summary

The objective of this trial is to evaluate the effectiveness and safeness of different doses of continuous Theta Burst Stimulation (cTBS) over the right Superior Frontal Gyrus (SFG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-stroke aphasia.

Eligibility Criteria

Inclusion

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

  • Diagnosed as aphasia patient according to the Chinese version of Western AphasiaBattery (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 nativelanguage is Chinese with at least 6 years of education;

  • Understand the trial and signed the informed consent form.

Exclusion

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, cochlearimplants, or other metal foreign bodies, or those with MRI contraindications such asclaustrophobia 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 andconfirmed 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 expectedsurvival time of less than 1 year;

  • Patients with severe hearing, visual, cognitive impairment or inability to cooperatewith the trial;

  • Patients with severe depression, anxiety, or diagnosed with other mental illnessesthat 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 suitablefor 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 ormay become pregnant during the trial;

  • Patients who are currently participating in other clinical trials.

Study Design

Total Participants: 60
Treatment Group(s): 6
Primary Treatment: active 2400-pulse continuous Theta Burst Stimulation
Phase:
Study Start date:
September 22, 2023
Estimated Completion Date:
December 22, 2025

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, investigators 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 double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized rTMS intervention in post-stroke aphasic patients.

Subjects will be randomly assigned to the following six groups: active 1200-pulse cTBS group, active 2400-pulse cTBS group, active 3600-pulse cTBS group, sham 1200-pulse cTBS group, sham 2400-pulse cTBS group, or sham 3600-pulse cTBS group. The allocation ratio will be 3:3:3:1:1:1. The stimulation protocol consisted of a 3-week treatment, with 5 consecutive workdays each week (totally 15 day-treatment). The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.

Connect with a study center

  • Nanshi Hospital of Nanyang

    Nanyang, Henan
    China

    Active - Recruiting

  • The fifth Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

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