rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Pat… (NCT06752499) | Clinical Trial Compass
CompletedNot Applicable
rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients
China60 participantsStarted 2023-02-20
Plain-language summary
The goal of this clinical trials is to investigate the effectiveness of 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 online rTMS intervention methods. The main questions it aims to answer are:
1. Does rTMS combined with motor training improve motor rehabilitation in patients？
2. Does repetitive transcranial magnetic stimulation (rTMS) combined with motor training enhance the upper limb motor rehabilitation ability in stroke patients by strengthening the functional coupling of the motor circuit to achieve functional reorganization of the brain network ?
Researchers will compare online rTMS to offline and sham stimulation in stroke patients to see if online rTMS works to alleviate motor dysfunction in multicenter multicenter, blinded and controlled trial.
Participants will:
1. randomized to one group(online, offline or sham);
2. receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
3. receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
4. conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
Who can participate
Age range20 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
✓. There is no pathological condition that is a contraindication for TMS in the medical history (for example, patients with metal in the brain, such as aneurysm clips, patients with a cardiac pacemaker, pregnant women, or those with a history of epileptic seizures).
✓. The patient or guardian agrees to sign the informed consent form.
Exclusion criteria
✕. Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
What they're measuring
1
Mean Change in FM-UE From Baseline
Timeframe: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)