Repetitive Transcranial Magnetic Stimulation Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine
RECRUITING
Shanghai
Shanghai Yang Zhi Rehabilitation Hospital
RECRUITING
Shanghai
Contact Information
Primary
Yang LIU, Master of Medicine
ly12446@rjh.com.cn
+8615821650228
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Online stimulation
5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Active_comparator: Offline stimulation
After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.
Sham_comparator: Sham stimulation
Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital
Collaborators: Shanghai Yangzhi Rehabilitation Hospital, shanghai center for brain science and brain-inspired technology, Changhai Hospital

This content was sourced from clinicaltrials.gov