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The effect and brain mechanism of repetitive transcranial magnetic stimulation based on PREP algorithm on the recovery of upper limb motor function after stroke: a stratified randomized controlled clinical trial

The effect and brain mechanism of repetitive transcranial magnetic stimulation based on PREP algorithm on the recovery of upper limb motor function after stroke: a stratified randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061813
Enrollment
Unknown
Registered
2022-07-03
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Upper limb motor dysfunction after stroke

Interventions

the contralesional cortex high-frequency rTMS group:with high-frequency rTMS on the contralesional M1 area (stimulation frequency of 10 Hz)
the contralesional cortex low frequency rTMS group:with low-frequency rTMS on the contralesional M1 area (stimulation frequency of 1 Hz)
the ipsilesional cortex high frequency rTMS group:with high frequency rTMS on the ipsilesional M1 area (stimulation frequency of 10 Hz)
the sham stimulation group:with the same stimulation site and stimulation parameters as the contralesional cortex low frequency rTMS group, but the coil is placed perpendicular to the skull to indicat

Sponsors

The First Affiliated Hospital of Gannan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for stroke in Chinese and Western medicine; 2. Aged 30-80 years, with no restriction on gender; 3. This is the first unilateral onset, with a duration of 2 weeks to 3 months; 4. Accompanied by upper limb motor dysfunction, with no restriction on the degree of limb impairment; 5. The patient is conscious and has sufficient cognitive ability to understand and perform tasks; 6. Can tolerate the detection of TMS and NIRS devices; 7. The skull is intact; 8. The mini-mental state examination (MMSE) is >= 21 points.

Exclusion criteria

Exclusion criteria: 1. Patients with other neurological diseases (e.g., traumatic brain injury, intracranial tumor, etc.) or serious systemic diseases such as cardiopulmonary diseases that cannot tolerate rehabilitation; 2. Patients with pre-existing limb motor dysfunction; 3. Patients with contraindications to TMS examination (e.g., implantation of metal instruments within 30 cm of the treatment site, history of epilepsy, etc.); 4. Patients who have used drugs that alter cortical excitability; 5. Patients who have participated in other clinical trials with phase intervention; 6. Patients who are pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
upper limb Fugl-Meyer assessment, UL-FMA;

Secondary

MeasureTime frame
modified Ashworth scale, MAS;functional independence measure, FIM;Latency and wave amplitude of motor evoked potentials, MEP;central motor conduction time, CMCT;Oxyhemoglobin concentration;Deoxyhemoglobin concentration;Total hemoglobin;

Countries

China

Contacts

Public ContactZhong Yanbiao

Department of Rehabilitation Medicine, the First Affiliated Hospital of Gannan Medical University

zhongyb2010@163.com+86 18201826956

Outcome results

None listed

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