NCT07049211Not yet recruiting
Individualized rTMS Synchronized Task Training for Closed-loop Neuromodulation of Post-stroke Motor Dysfunction
Individualized Closed-Loop Neuromodulation With Repetitive Transcranial Magnetic Stimulation Synchronized Task Training for Upper Limb Motor Dysfunction in Stroke Patients
Source: ClinicalTrials.gov · Last updated 3 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 online rTMS intervention methods. The main questions it aims to answer are: 1. Does individualized rTMS precise target combined with motor training improve upper limb motor rehabilitation in patients？ 2. Does individualized rTMS precise target 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 individualized online rTMS to non-individualized online and individualized sham stimulation in stroke patients to see if individualized online rTMS works to alleviate motor dysfunction in this randomized，sham-controlled, double-blind trial. Participants will: 1. randomized to one group(individualized online, non-individualized online 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 16 Jun 2025
- Start date
- 20 Jul 2025
- Primary completion date
- 20 Jan 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Stroke
- NCT number
- NCT07049211
What you commit to
- Study type: Interventional
- Planned participants: 51
- From 20 Jul 2025 to the primary completion date, 20 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
Other
- Those with severe visual or hearing impairments, unable to communicate normally;
Who the study is looking for
- 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.
- Motor evoked potentials(MEPs) of First Dorsal Interosseous Muscle（FDI）or Abductor Pollicis Brevis Muscle (APB) is negative in ipsilesional hemisphere.
- 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.
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine, Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.