pBFS-guided cTBS at Different Doses for Aphasia After Stroke

Stroke Clinical Trial

Official title:

Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy at Different Doses for Aphasia After Stroke: a RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969548
• Other study ID #: CPSA08HN60
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: September 22, 2025

Study information

• Verified date: September 2023
• Source: Changping Laboratory
• Contact: Ruiqi Pan
• Phone: 010-80726688
• Email: ruiqipanedu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 22, 2025
• Est. primary completion date: September 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• active 1200-pulse continuous Theta Burst Stimulation
Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
• active 2400-pulse continuous Theta Burst Stimulation
Each patient will receive two 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
• active 3600-pulse continuous Theta Burst Stimulation
Each patient will receive two 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
• sham 1200-pulse continuous Theta Burst Stimulation
Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
• sham 2400-pulse continuous Theta Burst Stimulation
Each patient will receive two sham 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
• sham 3600-pulse continuous Theta Burst Stimulation
Each patient will receive two sham 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.

Locations

Country	Name	City	State
China	Nanshi Hospital of Nanyang	Nanyang	Henan
China	The fifth Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Changping Laboratory

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Western Aphasia Battery scores	The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.	baseline, end of the 3-week therapy
Secondary	Change in the Western Aphasia Battery scores	The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.	baseline, end of the 5-day therapy, 90 days after treatment initiation
Secondary	Boston Diagnostic Aphasia Examination Severity Ratings	The Boston Diagnostic Aphasia Examination (BDAE) Severity Ratings is a clinical tool used to evaluate the severity and type of aphasia in individuals. The assessment includes four domains: communication abilities, language content, speech sound production and response abilities.BDAE severity ratings range from level 0 to level 5, with lower scores indicating more severe aphasia.	baseline,end of the 3-week therapy,90 days after treatment initiation
Secondary	Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)	The SAQOL-39g is a quality of life assessment tool that is used to evaluate the impact of stroke and aphasia on a patient's quality of life. It consists of 39 items that cover a range of domains related to the patient's quality of life, such as communication, physical functioning, mood, and social support. The items are rated on a 5-point Likert scale ranging from "not at all" to "very much", with higher scores indicating better quality of life.	baseline,end of the 3-week therapy,90 days after treatment initiation