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

NCT05929534 | Unknown

• 1 other identifier: CPSA04HLJ40
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

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 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 iTBS group

ACTIVE COMPARATOR

active iTBS combined with speech language therapy

Device: active intermittent Theta Burst Stimulation

sham iTBS group

SHAM COMPARATOR

sham iTBS combined with speech language therapy

Device: sham intermittent Theta Burst Stimulation

Interventions

active intermittent Theta Burst Stimulation DEVICE

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.

active iTBS group

sham intermittent Theta Burst Stimulation DEVICE

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.

sham iTBS 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 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.

You may not qualify if:

• 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);
• 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

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

Na Xu, PhD

CONTACT

010-80726688; naxu@cpl.ac.cn

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 24, 2023
• First Posted: July 3, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share