Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT

NCT05842304 | Recruiting

• 1 other identifier: CPSA0290
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic stroke aphasic patients.

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 21-day therapy

Secondary Outcomes (2)

• Change in the Western Aphasia Battery scores

  baseline, end of the 7-day therapy, end of the follow-up of 3 weeks

• National Institute of Health stroke scale

  baseline, end of the 21-day therapy

Study Arms (2)

active cTBS group

ACTIVE COMPARATOR

active cTBS combined with conventional rehabilitation therapy

Device: active cTBS

sham cTBS group

SHAM COMPARATOR

Sham cTBS combined with conventional rehabilitation therapy

Device: sham cTBS

Interventions

active cTBS DEVICE

Each patient will receive three 600-pulse cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks).

active cTBS group

sham cTBS DEVICE

Each patient will receive three 600-pulse sham cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks).

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 2 months and less than or equal to 1 year .
• 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, or with a history of stroke without apparent sequelae ( scored≤1 on modified Rankin Scale score (mRS) before the current 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:

• Patients with comorbid severe dysarthria (NIHSS item 10 dysarthria ≥ 2).
• Aphasia caused by other diseases such as brain tumor, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, traumatic brain injury, etc.
• Patients with MRI scan and TMS treatment contraindications, such as claustrophobia, cardiac pacemaker, cochlear implant or other metallic foreign body and any electronic device implanted in the body.
• History of epilepsy (having at least 2 uninduced seizures more than 24h apart, or a diagnosis of epilepsy syndrome, or having seizures within the past 12 months).
• Patients with severe combined cardiac, pulmonary, hepatic, renal and other systemic diseases that cannot be controlled by conventional medication.
• Patients with comorbid disorders of consciousness ( NIHSS 1(a)≥1).
• Patients with combined malignant hypertension (sudden and significant increase in blood pressure, with increased systolic and diastolic blood pressure, often persisting above 200/130 mmHg)
• Patients with co-malignant neoplasm.
• Patients with a life expectancy of less than 1 year due to causes other than stroke.
• Patients with combined deafness, visual impairment, or severe cognitive impairment to the extent that they are unable to cooperate with the test.
• Patients with severe depression, anxiety, or diagnosed with other mental disorders to the extent that they are unable to cooperate with the trial.
• History of TMS, transcranial electrical stimulation and other neuromodulation treatments in the past 3 months.
• History of alcohol, drug, and/or other abuse.
• Patients with other test abnormalities judged by the investigator to be unsuitable for the trial.
• Women of childbearing age who are pregnant or preparing for pregnancy.

Sponsors & Collaborators

• Changping Laboratory: lead

Study Sites (1)

China Rehabilitation Research Center

Beijing, 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, 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: April 24, 2023
• First Posted: May 6, 2023
• Study Start: June 5, 2023
• Primary Completion: May 10, 2025
• Study Completion (Estimated): May 10, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-05

Locations

CN (1)