About this trial
The goal of this clinical trials is to investigate the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of individualized online rTMS intervention methods. The main questions it aims to answer are:
Does rTMS synchronized with motor training improve motor rehabilitation in patients with the ability to induce motor evoked potentials(MEPs)? Dose individualized rTMS synchronized with motor training improve motor rehabilitation in patients without the ability to induce MEPs? Researchers will compare online rTMS to offline and sham stimulation in patients with MEPs to see if online rTMS works to alleviate motor dysfunction in preliminary trials. And compare individualized online rTMS to non-individualized online rTMS and sham in patients without MEPs to see if individualized online rTMS works to alleviate motor dysfunction in Randomized, double-blinded, and controlled trials.
Participants will:
randomized to one group acoording to the MEP condition of each person; receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks; receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment; conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
Eligibility criteria
Qualifiers
The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
The age is between 20 and 80 years old.
The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
Disqualifiers
Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
Those with a history of aphasia, severe cognitive impairment or mental illness;
Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
Those with severe visual or hearing impairments, unable to communicate normally;
Trial design
Treatments tested in this trial
- online rTMS
- offline rTMS
- sham rTMS
Treatment groups
Sponsors and collaborators
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Lead sponsor
shanghai center for brain science and brain-inspired technology
Collaborator