rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Online stimulation
- Conditions
- Stroke
- Sponsor
- Ruijin Hospital
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- Mean Change in FM-UE From Baseline
- Status
- Completed
- Last Updated
- 2 days ago
Overview
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:
- Does rTMS combined with motor training improve motor rehabilitation in patients？
- 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:
- randomized to one group(online, offline or sham);
- receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
- receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
- 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.
Investigators
Qing Xie, PhD
Professor
Ruijin Hospital
Eligibility Criteria
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;
- •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;
- •Those with severe visual or hearing impairments, unable to communicate normally;
- •People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
Arms & Interventions
Online stimulation
5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Intervention: Online stimulation
Offline stimulation
After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.
Intervention: Offline stimulation
Sham stimulation
Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Intervention: Sham stimulation
Outcomes
Primary Outcomes
Mean Change in FM-UE From Baseline
Time Frame: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance). FM-UE scale was assessed by site raters who were masked to the intervention).
Mean Change in FM-UE From Baseline
Time Frame: Day 105 （three months after 2-week intervention）
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance). FM-UE scale was assessed by site raters who were masked to the intervention).
Secondary Outcomes
- The average completion time for baseline tasks(Before intervention (Week 0); Middle of intervention (Week 1); After intervention (Week 2))
- Mean Change in ARAT score from Baseline(Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105))
- Mean Change in WMFT score from Baseline(Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105))
- Mean Change in MBI score from Baseline(Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105))
- Mean Change in PSQI score from Baseline(Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105))
- Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)(Before intervention (day 0); In the middle of intervention (day 6); After intervention (day15); Follow-up 1 (day 45); Follow-up 2 (day105))
- MRI changes(Before intervention (day 0); After intervention (day15))
- Adverse events(Before intervention (day 0); In the middle of intervention (day 6); After intervention (day15))
- Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)(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))
- Mean Change in ARAT score from Baseline(Day 105 （three months after 2-week intervention）)
- Mean Change in WMFT score from Baseline(Day 105 （three months after 2-week intervention）)
- Mean Change in MBI score from Baseline(Day 105 （three months after 2-week intervention）)
- Mean Change in PSQI score from Baseline(Day 105 （three months after 2-week intervention）)
- The average completion time for baseline tasks(Before intervention (Week 0); Middle of intervention (Week 1); After intervention (Week 2))