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A single blind, multicenter, randomized, pseudo stimulus controlled trial of peripheral combined central magnetic stimulation promoting motor function rehabilitation in ischemic stroke

A single blind, multicenter, randomized, pseudo stimulus controlled trial of peripheral combined central magnetic stimulation promoting motor function rehabilitation in ischemic stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071733
Enrollment
Unknown
Registered
2023-05-23
Start date
2023-06-15
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Upper limb dual target stimulation group:Stimulation site: brachial plexus (the center point of the coil is located on the inner side of the angle formed between the clavicle and humerus, as shown in
Stimulation parameters: High frequency (20Hz), stimulation for 2 seconds, with an interval of 3 seconds. Each treatment has a total of 2400 pulses for a total of 300 seconds. Intensity: Gradually incr
Upper limb central target stimulation group:Once a day, 5 days a week, for a total of 2 weeks of treatment. Using a conical magnetic stimulation coil, the M1 area of the affected cortical area was sti
Upper Limb Intelligent Rehabilitation Group:Once a day, 5 days a week, for a total of 2 weeks of treatment. Input the patient's evaluation data, and the intelligent rehabilitation platform recommends
Upper Limb Sham stimulation group:Once a day, 5 days a week, for a total of 2 weeks of treatment. During false stimulation, place the coil perpendicular to the stimulation site. Routine treatment: exe
lower limb dual target stimulation group:Stimulation site: lumbar plexus (outer half of the intersection point between the two iliac posterior superior spines at the center of the coil and the posteri
Stimulation parameters: High frequency (20Hz), stimulation for 2 sec

Sponsors

Tongji University Affiliated Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. First stroke, confirmed by cranial CT or MRI; 2. The onset time is between two weeks and two years; 3. Having motor dysfunction (upper limb FMA < 66 points or lower limb FMA < 34 points); 4. The patient has no significant cognitive impairment (normal MMSE).

Exclusion criteria

Exclusion criteria: 1. Previous history of stroke, brain trauma, brain tumor; 2. Complicated with severe heart, lung, liver, kidney dysfunction or other serious physical diseases; 3. Previous epilepsy and epilepsy family history; 4. Metals implanted in the human body, such as pacemakers and metals in the skull; 5. Those who have new infarcts or secondary bleeding, and their condition worsens; 6. Patients with severe cervical spondylosis, including severe cervical cone stenosis and cervical instability.

Design outcomes

Primary

MeasureTime frame
Changes in upper and lower limb motor function assessment (FMA) scores;

Secondary

MeasureTime frame
Modify Barthel Index (MBI);Berg balance scale;Holden walking function grading;Motor evoked potential, MEP;

Countries

China

Contacts

Public ContactChen Yuhui

Tongji University Affiliated Tongji Hospital

97780@tongji.edu.cn+86 21 6611 1141

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026