Dose-Response of rPMS for Upper Limb Hemiparesis after Stroke

Dose-Response of Repetitive Peripheral Magnetic Stimulation Therapy Combined with Intensive Occupational Therapy for Upper Limb Hemiparesis After Stroke: A Multi-Center Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032190191

Enrollment

Registered

2020-01-20

Start date

2020-02-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Stroke patients with upper limb hemiparesis Cerebrovascular Disease

Interventions

We will obtain the patient's informed consent one week prior to the admission and quickly check for the inclusion and exclusion criteria. Then, they will be registered for the study. At admission, the

rehabilitation therapy, functional magnetic stimulation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all the inclusion criteria below. 1) Stroke patients with upper limb hemiparesis between the age of 18 and 80. 2) 3 months past after the stroke onset. 3) The Brunnstrom stage of the upper limb is 3 to 4. 4) The general condition is stable. 5) Patients without cognitive impairment who are able to understand the study plan. 6) Patients who give written informed consent of one's own free will. 7) Gender: Female or Male. 8) Patients who are able to adhere to the study protocol, including hospitalization and outpatient visits. 9) Patients who have received botulinum toxin therapy for their paretic upper limb at least 15 days before the admission.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1) Patients with the self-contained medical implant (pacemaker, cochlear implant, or etc) 2) Patients with severe heart disease. 3) Patients with metal implants near the stimulation site of rPMS. 4) Patients with deep-vein thrombosis near the stimulation site of rPMS. 5) Patients with infection (such as acute cellulitis, etc) near the stimulation site of rPMS. 6) Pregnant women or suspected ones. 7) Patients considered not eligible for the study by the study researchers otherwise. 8) Patients who have unstable diseases or diseases that should be immediately treated (such as acute heart failure, acute kidney injury, severe diabetes, infection, etc). 9) Patients who have received the botulinum toxin therapy within 14 days of the admission.

Design outcomes

Primary

Measure	Time frame
The difference of the upper limb motor function (Fugl-Meyer Assessment) between the day before the treatment (Day 0) and the day after 2 weeks of the treatment (day 14).	—

Secondary

Measure	Time frame
1. Differences in spasticity between the time of admission (Day 0) and the day after two weeks of treatment (Day14) 2. Differences in motor evoked potential between the day after admission (Day 1) and the day after two weeks of treatment (Day 14) 3. Differences in active range of motion between the time of admission (Day 0) and the day after two weeks of treatment (Day 14) 4. Differences in activity of daily living between the time of admission (Day 0) and the day after two weeks of treatment (Day 14) 5. Differences in FMA score between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 6. Differences in spasticity between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 7. Differences in motor evoked potential between the day after admission (Day 1) and the day after four weeks of treatment (Day 28) 8. Differences in active range of motion between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 9. Differences in activity of daily living between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 10. Differences in FMA score between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 11. Differences in spasticity between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 12. Differences in motor evoked potential between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 13. Differences in activities of daily living between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 14. Differences in active range of motion between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 15. Immediate change of FMA score after the first session of rPMS therapy 16. Immediate change of motor evoked potential after the first session of rPMS therapy 17. Immediate change	—

Measure

Time frame

1. Differences in spasticity between the time of admission (Day 0) and the day after two weeks of treatment (Day14) 2. Differences in motor evoked potential between the day after admission (Day 1) and the day after two weeks of treatment (Day 14) 3. Differences in active range of motion between the time of admission (Day 0) and the day after two weeks of treatment (Day 14) 4. Differences in activity of daily living between the time of admission (Day 0) and the day after two weeks of treatment (Day 14) 5. Differences in FMA score between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 6. Differences in spasticity between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 7. Differences in motor evoked potential between the day after admission (Day 1) and the day after four weeks of treatment (Day 28) 8. Differences in active range of motion between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 9. Differences in activity of daily living between the time of admission (Day 0) and the day after four weeks of treatment (Day 28) 10. Differences in FMA score between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 11. Differences in spasticity between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 12. Differences in motor evoked potential between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 13. Differences in activities of daily living between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 14. Differences in active range of motion between the two weeks after admission (Day 14) and the day after four weeks of treatment (Day 28) 15. Immediate change of FMA score after the first session of rPMS therapy 16. Immediate change of motor evoked potential after the first session of rPMS therapy 17. Immediate change

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Contacts

Public ContactGentaro Hashimoto

The Jikei University Daisan Hospital

gentaro@jikei.ac.jp+81-3-3480-1151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026