Stroke, IschemicNCT05929534

pBFS-guided iTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke

A study testing active intermittent Theta Burst Stimulation in people with Stroke, Ischemic and Aphasia, run by Changping Laboratory.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The objective of this trial is to evaluate the effectiveness and safeness of intermittent Theta Burst Stimulation (iTBS) over the left Superior Temporal Gyrus (STG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia. Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Stroke, Ischemic, Aphasia
What is being tested?: active intermittent Theta Burst Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: No sites listed yet
Study dates: 1 Jul 2023to 30 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient's age ranges from 35 to 75 years old (including 35 and 75 years old);
Meet the diagnostic criteria for acute ischemic stroke (diagnosed according to the "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" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, and a duration of ≥15 days and ≤3 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.

Who cannot join

Combined severe 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 objects, 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);

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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.

Trial locations and contacts

No sites are listed yet.

Na Xu, PhD contact

010-80726688

naxu@cpl.ac.cn

About this study

Official title: Personalized Brain Functional Sector-guided Intermittent Theta Burst Stimulation Therapy Targeting at the Superior Temporal Gyrus for Aphasia After Ischemic Stroke: a RCT

Read the 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 Sector (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 sham controlled 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 two groups: active intermittent TBS (iTBS) group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol consists of a 3-week treatment, with five consecutive days each week (totally 15 day-treatment) . The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.

Conditions: Stroke, Ischemic, Aphasia
Being tested: active intermittent Theta Burst Stimulation, sham intermittent Theta Burst Stimulation
Medical subject headings: Ischemic Stroke, Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

active intermittent Theta Burst StimulationDevice
Each patient will receive two 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.
sham intermittent Theta Burst StimulationDevice
Each patient will receive two sham 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.

Study groups in NCT05929534
Study group	Role	What they receive
active iTBS group	Active comparator	active iTBS combined with speech language therapy Receives: Device: active intermittent Theta Burst Stimulation
sham iTBS group	Sham comparator	sham iTBS combined with speech language therapy Receives: Device: sham intermittent Theta Burst Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline, end of the 3-week therapy

Secondary outcomes (4)

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.
Measured: baseline, end of the 5-day therapy, 90 days after treatment initiation
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 1 to level 5, with higher scores indicating more severe aphasia.
Measured: baseline，end of the 3-week therapy，90 days after treatment initiation
Token test
The Token Test is a language assessment tool used to evaluate a person's ability to understand spoken language and follow instructions. Each correct response in each task is awarded one point, typically. Different point values may be assigned based on the complexity of the task. The total score is calculated by adding up the accumulated scores across all tasks. The total scores range from 0 to 36, with higher scores indicating better language abilities.
Measured: baseline，end of the 3-week therapy，90 days after treatment initiation
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.
Measured: baseline，end of the 3-week therapy，90 days after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202330 Jun 2025

First posted3 Jul 2023
Study start1 Jul 2023 (estimated)
Primary completion30 Jun 2024 (estimated)
Study completion30 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stroke, IschemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05929534
Sponsor's protocol ID: CPSA04HLJ40
Status last verified: Jul 2023
First submitted: 24 Jun 2023
Last updated: 10 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Na Xu, PhD

010-80726688

naxu@cpl.ac.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke, Ischemic trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Brain Functional Sector-guided Intermittent Theta Burst Stimulation Therapy Targeting at the Superior Temporal Gyrus for Aphasia After Ischemic Stroke: a RCT
ClinicalTrials.gov ID: NCT05929534
Acronym / sponsor ID: CPSA04HLJ40
Conditions: Stroke, Ischemic, Aphasia
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Changping LaboratoryUniversity, hospital or other
Study start: 1 Jul 2023 (estimated)
Primary completion: 30 Jun 2024 (estimated)
Study completion: 30 Jun 2025 (estimated)
First posted: 3 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
active iTBS group	Active comparator	Device: active intermittent Theta Burst Stimulationactive iTBS combined with speech language therapy
sham iTBS group	Sham comparator	Device: sham intermittent Theta Burst Stimulationsham iTBS combined with speech language therapy

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The patient's age ranges from 35 to 75 years old (including 35 and 75 years old);
Meet the diagnostic criteria for acute ischemic stroke (diagnosed according to the "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" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, and a duration of ≥15 days and ≤3 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;

Key exclusion criteria (16 listed)

Combined severe 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 objects, 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；

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
active intermittent Theta Burst StimulationEach patient will receive two 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.	Device	active iTBS group
sham intermittent Theta Burst StimulationEach patient will receive two sham 600-pulse iTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with five consecutive days each week.	Device	sham iTBS group

Primary outcome

Change in the Western Aphasia Battery scores
Time frame: baseline, end of the 3-week therapy
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.

4 secondary outcomes

Change in the Western Aphasia Battery scores
Time frame: baseline, end of the 5-day therapy, 90 days after treatment initiation
Boston Diagnostic Aphasia Examination Severity Ratings
Time frame: baseline，end of the 3-week therapy，90 days after treatment initiation
Token test
Time frame: baseline，end of the 3-week therapy，90 days after treatment initiation
Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
Time frame: baseline，end of the 3-week therapy，90 days after treatment initiation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
Individual participant dataSharing planned: No

Related trials for Stroke, Ischemic

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Na Xu, PhD contact

010-80726688

naxu@cpl.ac.cn

Hesheng Liu, PhD study chair

Changping Laboratory

Questions about this trial

What is this clinical trial studying?

A study testing active intermittent Theta Burst Stimulation in people with Stroke, Ischemic and Aphasia, run by Changping Laboratory.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Na Xu, PhD (010-80726688, naxu@cpl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Western Aphasia Battery scores (time frame: baseline, end of the 3-week therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05929534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.