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

NCT ID: NCT06415734

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

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

control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

rTMS

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

Intervention Type: DEVICE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Zhaolu Wang

Role: CONTACT

zhaoluwang@njmu.edu.cn

+86 18100613663

Facility Contacts

Role: primary

zhaoluwang@njmu.edu.cn

18100613663

Other Identifiers

202405n

Identifier Type: -

Identifier Source: org_study_id