Effect of Repetitive Transcranial Magnetic Stimulation on Neurological Recovery in Patients With Ischaemic Stroke

NCT06415734 | Not Yet Recruiting

• 1 other identifier: 202405n
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if transcranial magnetic stimulation(rTMS) can improve neurological rehabilitation in patients with acute ischemic stroke. The main questions it aims to answer are: Can rTMS Promote Recovery of Limb Impairment in Patients with Acute Ischemia? Can rTMS Cause Changes in the Functional Connections of Brain Networks in Patients? Researchers will compare rTMS therapy to non-stimulation therapy to see if rTMS is effective in promoting neurological recovery from ischemic stroke. Participants will: Receive rTMS or sham stimulation with LF-rTMS on the contralateral M1 of the brain lesion for 20 minutes, 1200 pulses, 120% RMT, and a treatment period of 5 days； Be evaluated on a scale before and after treatment

Conditions

Stroke Ischemic

Keywords

rTMS; stroke Ischemic

Outcome Measures

Primary Outcomes (1)

• Improvement in patient motor function

  Fugl-Meyer assessment scale，FMA Score: Minimum: 0 points, Maximum: 100 points The higher the score, the better the limb function.

  Before patient treatment and 5 days after patient treatment

Secondary Outcomes (1)

• Altered functional connectivity of brain networks in patients

  Patient before and after treatment on the first and fifth day of treatment and during rTMS treatment

Study Arms (2)

rTMS

EXPERIMENTAL

Subjects were treated with transcranial magnetic stimulation with the addition of a figure-of-eight coil on top of conventional western medicine treatment, and the treatment modalities were all LF-rTMS 20 min, 1200 pulses, 120% RMT in M1 contralateral to the brain lesion, with a treatment cycle of 5 days. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day.

Device: rTMS

control

NO INTERVENTION

Patients received only conventional Western medications. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day.

Interventions

rTMS DEVICE

LF-rTMS of M1 contralateral to the brain lesion for 20 min, 1200 pulses, 120% RMT, treatment cycle of 5 days

rTMS

Eligibility Criteria

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

You may qualify if:

• The age range is 18\~75 years old
• Meet the diagnostic criteria of China Acute Ischaemic Stroke Diagnosis and Treatment Guidelines 2018 and confirmed by head CT or MRI scanning
• Acute stage of the disease \<14 days and stable condition
• Stroke patients with only unilateral limb involvement (without bilateral cerebrovascular lesions)
• Patients with upper limb muscle strength ≥ grade 3, able to perform fNIRS tasks with the patient.
• Subjects were right-handed
• Participants give their informed consent and sign an informed consent form

You may not qualify if:

• Those who have metal implants or any electronic devices in their body
• Those with previous epilepsy or mental abnormality.
• Combined with serious heart, liver, lung and other important organ failure
• Those who have brain haemorrhage or bleeding tendency.
• Deteriorating condition, new cerebral infarction or secondary cerebral haemorrhage.
• Patients with history of craniocerebral trauma and craniocerebral surgery.
• Those with severe cognitive and communication disorders who are unable to cooperate -

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zhaolu Wang

CONTACT

+86 18100613663; zhaoluwang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: July 1, 2024
• Primary Completion: August 15, 2024
• Study Completion: September 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)