pBFS-guided Dual-target cTBS for Aphasia After Stroke

NCT05957354 | Recruiting

• 1 other identifier: CPSA05SD60
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this trial is to evaluate the effectiveness and safeness of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) for language function recovery in post-stroke aphasic patients.

Conditions

Stroke; Aphasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the Western Aphasia Battery scores

  baseline, end of the 5-day therapy, 90 days after treatment initiation

• Boston Diagnostic Aphasia Examination Severity Ratings

  baseline, end of the 3-week therapy，90 days after treatment initiation

• Token test

  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)

  baseline，end of the 3-week therapy，90 days after treatment initiation

Study Arms (2)

active cTBS group

ACTIVE COMPARATOR

active cTBS combined with speech language therapy

Device: active continuous Theta Burst Stimulation

sham cTBS group

SHAM COMPARATOR

sham cTBS combined with speech language therapy

Device: sham continuous Theta Burst Stimulation

Interventions

active continuous Theta Burst Stimulation DEVICE

Each patient will receive a combination of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.

active cTBS group

sham continuous Theta Burst Stimulation DEVICE

Each patient will receive a combination of stimulation sequences, including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.

sham cTBS group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Changping Laboratory: lead

Study Sites (2)

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hesheng Liu, PhD

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Ruiqi Pan

CONTACT

010-80726688; ruiqipanedu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: July 28, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)