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The effect of iTBS targeted on DLPFC and M1 on the effectiveness of BCI training and its mechanisms

The effect of iTBS targeted on DLPFC and M1 on the effectiveness of BCI training and its mechanisms

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097678
Enrollment
Unknown
Registered
2025-02-24
Start date
2024-01-22
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Stroke

Interventions

Experimental group of stroke patients:Intermittent Theta-Burst Stimulation (iTBS) and Upper-Limb Rehabilitation Training with Brain–Computer Interface (BCI): Participants received a three-week interv
Control group of stroke patients:Sham iTBS and Upper-Limb Rehabilitation Training with Brain–Computer Interface (BCI) in the Pre-Frontal Cortex and Motor Cortex Regions (Three-Week Intervention)
Experimental group of healthy subjects:One Week of BCI Upper-Limb Rehabilitation Training, Followed by a Single Session of Real iTBS in the Prefrontal Cortex and Motor Cortex Combined with BCI Upper-L
Control group of healthy subjects:One Week of BCI Upper-Limb Rehabilitation Training, Followed by a Single Session of Sham iTBS in the Prefrontal Cortex and Motor Cortex Combined with BCI Upper-Limb R

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for stroke patients: (2)Upper-limb motor function impairment as evidenced by clinical presentation within 18 months post-stroke. (2)Montreal Cognitive Assessment (MoCA) score >= 22. (3)Bilateral visual acuity or corrected visual acuity >= 1.0 as assessed by the international standard visual acuity chart. (4)No metallic implants in the body. (5)Ability to follow instructions for testing procedures. (6)Voluntary provision of informed consent. Inclusion criteria for healthy participants: (1)Good general health status. (2)No neuromuscular diseases or pain in the upper limbs, with normal joint range of motion. (3)No history of upper-limb trauma or surgery within the past three years. (4)No history of neurological or psychiatric disorders. (5)Bilateral visual acuity or corrected visual acuity >= 1.0 as assessed by the international standard visual acuity chart. (6)No metallic implants in the body. (7)Voluntary provision of informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for stroke patients: (1) Non-unilateral hemispheric stroke. (2) History of previous stroke, brain tumor, traumatic brain injury, or other neurological or psychiatric disorders. (3) Presence of cognitive impairment. (4) Severe comorbidities involving the heart, lungs, liver, pancreas, kidneys, or other major organs. (5) Severe visual impairment. (6) Inability to cooperate with assessments or treatments. (7) Refusal to provide informed consent. Exclusion criteria for healthy participants: (1) Upper-limb motor dysfunction or pain due to neuromuscular diseases or trauma. (2) History of traumatic brain injury, stroke, or other neurological disorders. (3) Pregnancy. (4) Inability or unwillingness to cooperate with assessments. (5) Refusal to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment Scale, FMAS;Cognitive function tests;

Secondary

MeasureTime frame
Action Research Arm Test;ability of motor imagery;Intrinsic Motivation Inventory;

Countries

China

Contacts

Public ContactQian Ding

Department of Rehabilitation Medicine, Guangdong Provincial People's Hospital

dingqianyear@163.com+86 137 1023 3020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 3, 2026