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Immediate effects of rTMS combined with brain-computer interface intervention on brain functional connectivity in stroke patients: a prospective near-infrared spectroscopy study

Immediate effects of rTMS combined with brain-computer interface intervention on brain functional connectivity in stroke patients: a prospective near-infrared spectroscopy study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092940
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-31
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Stroke

Interventions

Health group(HP):For 5 consecutive days, once/day, 20 minutes/time, brain-computer interface training
Stroke Attention-impaired Group (SOAD):For 5 consecutive days, once/day, 20 minutes/time, brain-computer interface training
Stroke Attention Disorder Group (SWAD):For 5 consecutive days, once/day, 20 minutes/time, brain-computer interface training
Healthy DLPFC group(HDLPFC):For 5 consecutive days, once a day, 10HZ rTMS (20min DLPFC as the target) + brain-computer interface training (20min)
Stroke DLPFC group(SDLPFC):For 5 consecutive days, once a day, 10HZ rTMS (20min DLPFC as the target) + brain-computer interface training (20min)
Health fake stimulation group(HFG):For 5 consecutive days, once a day, 10HZ rTMS (20min fake stimulation) + brain-computer interface training (20min)
Stroke fake stimulation group(SFG):For 5 consecutive days, once a day, 10HZ rTMS (20min fake stimulation) + brain-computer interface training (20min)

Sponsors

The Fifth Affiliated Hospital of Guangzh Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Part I: Inclusion criteria of healthy subjects: (1) Aged 18-75 years, including 18 and 75 years; (2) limbs sound, no motor dysfunction: (3)MMSE>=27 points: voluntarily sign the informed consent. Inclusion criteria: (1) Stroke patients diagnosed in accordance with the diagnosis of cerebrovascular diseases in the Chinese Classification of Cerebrovascular Diseases 2019; (2) Cerebral stroke confirmed by CT or MRI; (3) Cerebral apoplexy resulting in one upper limb dysfunction, Burunnstrom hand stage 1-5: (4) age 18-75 years old, including 18 and 75 years old; Simple mental State Examination Scale (MMSE) 6 years; (3) No obvious impairment of vision and hearing; (4) The score of the simple mental State Examination Scale (MMSE) is >=27 points; (5) The Edinburgh Handedness Inventory was right-handed; (6) Agree to participate and sign informed consent. Stroke inclusion criteria: (1) Stroke patients diagnosed with cerebrovascular diseases in accordance with the diagnostic points of Chinese Classification of Cerebrovascular Diseases 2019; (2) Cerebral stroke confirmed by CT or MRI; (3) Cerebral apoplexy resulting in one upper limb dysfunction, Burunnstrom hand stage 1-5: (4) age 18-75 years old, including 18 and 75 years old; Simple mental State Examination Scale (MMSE) <27 points, can understand and cooperate with the completion of the experiment; (5) Edinburgh Handedness Scale was assessed as right-handedness; (6)Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with previous brain-related diseases affecting cognitive function; 2. There are previous diseases that affect exercise ability, such as fracture history, brain injury history, limb pain, etc.; 3. suffering from serious mental disorders; 4. Taking drugs that affect cognitive function; 5. Patients with serious heart, lung, liver, kidney or other system diseases, malignant tumors and epilepsy; 6. Those who do not cooperate to complete the assessment; 7. Pregnancy, need to improve pregnancy examination; 8. Any implanted device or metal may be affected by magnetic fields generated by transfrequency magnetic stimulation.

Design outcomes

Primary

MeasureTime frame
Oxy-hemoglobin,HbO;

Secondary

MeasureTime frame
Bci response rate;n-back normal form correct rate;n-back paradigm response time;

Countries

China

Contacts

Public ContactHaining Ou\Zirui Luo

Guangdong Hospital of Traditional Chinese Medicine\The Fifth Affiliated Hospital of Guangzhou Medical University

827367058@qq.com+86 186 8890 6213

Outcome results

None listed

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