pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke

NCT05907031 | Recruiting

• 1 other identifier: CPSA02FJ30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke, Ischemic; 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 into an Aphasia Quotient, lower scores indicate worse outcomes.

  baseline, end of the 3-week therapy

Secondary Outcomes (3)

• Change in the Western Aphasia Battery scores

  baseline, end of the 5-day therapy, end of the follow-up of 3 weeks

• Boston Diagnostic Aphasia Examination Severity Ratings

  baseline，end of the 3-week therapy，end of the follow-up of 3 weeks

• Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)

  baseline，end of the 3-week therapy，end of the follow-up of 3 weeks

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 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 days each week.

active cTBS group

sham continuous Theta Burst Stimulation DEVICE

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 days 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:

• Patients between the ages of 35 and 75 years (including 35 and 75 years).
• Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association 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 and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months .
• Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8.
• First onset stroke.
• Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education).
• Understand the trial and be able to provide informed consent.

You may not qualify if:

• Combined severe dysarthria (NIHSS item 10 score ≥ 2 points);
• Aphasia caused by bilateral hemispheric stroke, brain tumors, 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;
• Patients with severe systemic diseases such as heart, lung, liver, kidney diseases, etc., which cannot be controlled by routine medications as confirmed by laboratory tests and examinations;
• Impaired consciousness (NIHSS item 1(a) score ≥ 1 point);
• Malignant hypertension;
• Malignant tumor;
• Patients with a life expectancy of less than 1 year due to reasons other than stroke;
• Severe hearing, visual, or cognitive impairments that prevent the patient from completing the trial;
• Patients with severe depression, anxiety, or other mental illnesses that prevent them from completing the trial;
• Patients who have received other neuroregulatory treatments such as TMS or transcranial electrical stimulation within 3 months before enrollment;
• History of alcohol abuse, drug abuse, or other substance abuse;
• Patients with other abnormal test results that make them unsuitable for participating in this trial as determined by the researchers;
• Women of childbearing age who are pregnant or planning to become pregnant;

Sponsors & Collaborators

• Changping Laboratory: lead
• First Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Aphasia

Condition Hierarchy (Ancestors)

Stroke; 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

Jianting Huang, MD,PhD

CONTACT

010-80726688; jianting.huang@pku.edu.cn

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: June 8, 2023
• First Posted: June 18, 2023
• Study Start: August 23, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-09

Locations

CN (1)