Clinical trial NCT05969548: pBFS-guided cTBS at Different Doses for Aphasia After Stroke
Official title: Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy at Different Doses for Aphasia After Stroke: a RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Aphasia
Lead sponsor: Changping Laboratory
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Change in the Western Aphasia Battery scores
timeFrame: baseline, end of the 3-week therapy
Secondary outcomes:
measure: Change in the Western Aphasia Battery scores
timeFrame: baseline, end of the 5-day therapy, 90 days after treatment initiation
measure: Boston Diagnostic Aphasia Examination Severity Ratings
timeFrame: baseline，end of the 3-week therapy，90 days after treatment initiation
measure: Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
timeFrame: baseline，end of the 3-week therapy，90 days after treatment initiation
Other outcomes:
Locations:
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
state: Henan
city: Zhengzhou
country: China
facility: The fifth Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Changping Laboratory
name: Hesheng Liu, PhD
role: STUDY_CHAIR
References: