pBFS-guided cTBS Combined With iTBS Over the Superior Frontal Gyrus for Aphasia After Ischemic Stroke

NCT06086938 | Unknown

• 1 other identifier: CPSA07BJ40
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study aims to evaluate the efficacy and safety of pBFS-guided cTBS combined with iTBS for the rehabilitation of language functions 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 (3)

• 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

• 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 TBS group

ACTIVE COMPARATOR

active TBS combined with speech language therapy

Device: active cTBS combined with iTBS

sham TBS group

SHAM COMPARATOR

sham TBS combined with speech language therapy

Device: sham cTBS combined with iTBS

Interventions

active cTBS combined with iTBS DEVICE

Daily TBS treatment consists of the following combination: active 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + active 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + active 600-pulse cTBS applied to the SFG in the unaffected hemisphere + active 600-pulses iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.

active TBS group

sham cTBS combined with iTBS DEVICE

Daily sham TBS treatment consists of the following combination: sham 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + sham 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + sham 600-pulse cTBS applied to the SFG in the unaffected hemisphere + 600-pulse sham iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of sham TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.

sham TBS 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 functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school；
• 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 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 neuroregulatory 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, Ph.D.

  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: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 20, 2023
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10