Clinical trial NCT06415734: Effect of Repetitive Transcranial Magnetic Stimulation on Neurological Recovery in Patients With Ischaemic Stroke
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Ischemic
Keywords: rTMS
stroke Ischemic
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 \&lt;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 -

Primary outcomes:
measure: Improvement in patient motor function
timeFrame: Before patient treatment and 5 days after patient treatment
Secondary outcomes:
measure: Altered functional connectivity of brain networks in patients
timeFrame: Patient before and after treatment on the first and fifth day of treatment and during rTMS treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
Study officials:
References: