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

Not Applicable

Not yet recruiting

• Conditions: Stroke Ischemic
• Interventions: Device: rTMS

• Registration Number: NCT06415734
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-16
• Last Update Posted: 2024-06-18
• Study Start: 2024-07-01
• Primary Completion: 2024-08-15
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS	rTMS	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.

Primary Outcome Measures

Name	Time	Method
Improvement in patient motor function	Before patient treatment and 5 days after patient treatment	Fugl-Meyer assessment scale，FMA Score: Minimum: 0 points, Maximum: 100 points The higher the score, the better the limb function.

Secondary Outcome Measures

Name	Time	Method
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	data from near-infrared functional brain imaging acquisitions

Trial Locations

Locations (1)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China