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 range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used repetitive TMS combined with motor training specifically for arm and hand weakness after stroke — given my particular type of stroke and how much arm function I've lost, is this kind of combined approach something worth exploring for my situation?
2The trial is already completed and was measuring average change in arm movement scores using the Fugl-Meyer Upper Extremity scale — have the results been published yet, and what do they suggest about how much real-world improvement patients actually experienced?
3Since this study was listed as 'Phase NA,' it may not have been a standard drug trial with the usual phase-based safety testing — what does that mean for how well we understand the risks of repetitive TMS combined with motor training at this point?
4Are there standard rehabilitation therapies or existing rTMS protocols already available to me that I should try first, before considering an experimental combined approach like the one studied in this trial?
5How would I know if I was a good candidate for the type of rTMS and motor training used in this study — are there stroke characteristics, like timing since my stroke or the location of brain injury, that would make this approach more or less likely to help me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)