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

Stroke Ischemic Clinical Trial

Official title:

Repeated Transcranial Magnetic Stimulation (rTMS) Promotes Neural Function Recovery in Patients With Ischemic Stroke by Affecting Local Cerebral Blood Flow and Brain Network

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415734
• Other study ID #: 202405n
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zhaolu Wang
• Phone: +86 18100613663
• Email: zhaoluwang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke Ischemic

Intervention

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

Locations

Country	Name	City	State
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Altered functional connectivity of brain networks in patients	data from near-infrared functional brain imaging acquisitions	Patient before and after treatment on the first and fifth day of treatment and during rTMS treatment