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Clinical Trials/NCT06415734
NCT06415734
Not Yet Recruiting
N/A

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

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country40 target enrollmentJuly 1, 2024
ConditionsStroke Ischemic

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke Ischemic
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment
40
Locations
1
Primary Endpoint
Improvement in patient motor function
Status
Not Yet Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
September 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 -

Outcomes

Primary Outcomes

Improvement in patient motor function

Time Frame: 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 Outcomes

  • 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 Sites (1)

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