Clinical trial NCT06752499: rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients
Official title: Repetitive Transcranial Magnetic Stimulation Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: Repetitive Transcranial Magnetic Stimulation
Upper Limb Motor Dysfunction
online
motor task training
individualized
Motor evoked potentials
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Shanghai Yangzhi Rehabilitation Hospital
name: shanghai center for brain science and brain-inspired technology
First posted: 2024-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this study, patients were be randomly assigned to three groups: online, offline and sham groups. if patients were able to induce MEPs, intensity of TMS will be 80% RMT; if not , inensity of TMS will be 70%\~80% of TMS output.

Patients were stimulated over 2 week period, 4 sessions of tasks were performed everyday. The patient will undergo a 2-week (10-day) stimulation protocol, with fourty tasks performed daily. This includes one session of 10 baseline tasks measurement and three sessions of 5 Hz rTMS synchronized with 10 motor tasks. rTMS will be applied to the ipsilesional motor cortex.

Eligibility criteria: Inclusion Criteria:

1. The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
2. The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
3. The age is between 20 and 80 years old.
4. The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
5. There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
6. 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).
7. The patient or guardian agrees to sign the informed consent form.

Exclusion Criteria:

1. Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
2. Those with a history of aphasia, severe cognitive impairment or mental illness;
3. Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
4. Those with severe visual or hearing impairments, unable to communicate normally;
5. People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.

Primary outcomes:
measure: Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
timeFrame: Before intervention (Week 0); After intervention (Week 2); Follow-up 1 (one month after intervetnion); Follow-up 2 (three months after intervention)
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Before intervention (Week 0); After intervention (Week 2); Follow-up 1 (one month after intervetnion); Follow-up 2 (three months after intervention)
measure: Wolf motor function test (WMFT)
timeFrame: Before intervention (Week 0); After intervention (Week 2); Follow-up 1 (one month after intervetnion); Follow-up 2 (three months after intervention)
measure: Modified Barthel Index (MBI)
timeFrame: Before intervention (Week 0); After intervention (Week 2); Follow-up 1 (one month after intervetnion); Follow-up 2 (three months after intervention)
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Before intervention (Week 0); After intervention (Week 2); Follow-up 1 (one month after intervetnion); Follow-up 2 (three months after intervention)
measure: Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)
timeFrame: Before intervention (Week 0); In the middle of intervention (Week 1); After intervention (Week 2); Follow-up 1 (one month after intervetnion); Follow-up 2 (three months after intervention)
measure: The average completion time for baseline tasks
timeFrame: Before intervention (Week 0); Middle of intervention (Week 1); After intervention (Week 2)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Yang Zhi Rehabilitation Hospital
state: Songjiang
city: Shanghai
country: China
facility: Changhai Hospital
state: Yangpu
Study officials:
References: