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The study on the mechanism of vagus-mediated closed-loop feedback of brain-computer interface on neural remodeling of motor dysfunction after stroke

The study on the mechanism of vagus-mediated closed-loop feedback of brain-computer interface on neural remodeling of motor dysfunction after stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104317
Enrollment
Unknown
Registered
2025-06-16
Start date
2025-06-16
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Stroke

Interventions

ta-VNS intervention group (stroke):ta-VNS stimulation was performed only.ta-VNS stimulation was performed only.
ta-VNS synchronous feedback MI-BCI group (stroke):During MI-BCI training, the subjects were given synchronous ta-VNS intervention.
ta-VNS non-synchronous intervention MI-BCI group (stroke):Before MI-BCI training, ta-VNS intervention was performed on the subjects.
ta-VNS sham stimulation MI-BCI group (stroke):During MI-BCI training, ta-VNS sham stimulation was performed on the subjects.
ta-VNS synchronous feedback MI-BCI group (healthy subjects):During MI-BCI training, the subjects were given synchronous ta-VNS intervention.
ta-VNS non-synchronous intervention MI-BCI group (healthy subjects):Before MI-BCI training, ta-VNS intervention was performed on the subjects.
ta-VNS sham stimulation MI-BCI group (healthy subjects):During MI-BCI training, ta-VNS sham stimulation was performed on the subjects.
ta-VNS intervention group (healthy subjects):ta-VNS stimulation was performed only.ta-VNS stimulation was performed only.

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen Universit(Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Stroke patients: 1. Diagnostic criteria for stroke (including cerebral hemorrhage and cerebral infarction) formulated by the Fourth National Academic Conference on Cerebrovascular Diseases; 2. The first onset of the disease, and the brain CT or MRI examination confirmed as cerebral hemorrhage or cerebral infarction, the course of the disease >=6 months; 3. Age between 18~80 years old, including 18 years old and 80 years old, gender is not limited; 4. Mini-Mental Status Examination (MMSE) >=21 points, able to cooperate with the completion of the experiment; 5. Upper limbs and hands with post-stroke motor dysfunction; 6. Stable vital signs; 7. All patients signed the informed consent form for treatment and completed the basic information collection. Health Study Participants: 1. Health study participants aged 18 ~ 50 years old, gender is not limited; 2. Right-handed> 40 right-handed study participants who were examined by Edinburgh hand; 3. Healthy study participants with no history of psychiatric illness; 4. Healthy study participants with no obvious organ function impairment; 5. Health study participants voluntarily sign the informed consent form and complete the basic information collection.

Exclusion criteria

Exclusion criteria: 1. Previous bilateral or unilateral vagus nerve injury, study participants who have undergone vagus nerve surgery; 2. Study participants who are using a pacemaker or other neurostimulator in vivo; 3. Study participants with cognitive impairment; 4. Study participants with infection, ulcers, or scars at the site of irritation. 5. Study participants with a heart rate of less than 60 beats per minute (bradycardia). 6. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Upper Limb Motor Function Score;

Secondary

MeasureTime frame
Electroencephalogram index;

Countries

China

Contacts

Public ContactQiang Lin

The Seventh Affiliated Hospital of Sun Yat-sen Universit(Shenzhen)

linqiang@sysush.com+86 189 2249 7674

Outcome results

None listed

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