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The effect of central combine peripheral Intermittent Theta-Burst Stimulation (iTBS) on swallowing disorders after infratentorial stroke: a prospective, single blind, single center randomized controlled trial

The effect of central combine peripheral Intermittent Theta-Burst Stimulation (iTBS) on swallowing disorders after infratentorial stroke: a prospective, single blind, single center randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093702
Enrollment
Unknown
Registered
2024-12-10
Start date
2025-02-10
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

infratentorial stroke patients with swallowing disorders.

Interventions

Group A:central combine peripheral Intermittent Theta-Burst Stimulation (iTBS)
Group B:central Intermittent Theta-Burst Stimulation (iTBS)

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.first-ever brainstem stroke or cerebellar stroke,comply with the '2018 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 'or the '2014 Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage',documented by computed tomography (CT) or magnetic resonance imaging (MRI); 2.duration after stroke >=2weeks and <=12 months,stable condition; 3.18-85 years; 4.swallowing problems after stroke; 5.clear consciousness, stable vital signs and cooperate well with the training; 6.follow the research procedures and cooperate with the implementation of the whole process research; 7.follow the lifestyle precautions during the study; 8.willing to sign the informed consent of this study;

Exclusion criteria

Exclusion criteria: 1.a history of swallowing problems caused by other underlying neurological diseases, such as Parkinson’s disease, dementia, or motor neuron disease; 2.a history of intractable seizure; 3.poor cooperation due to serious aphasia or cognitive disorders; 4.serious dysfunction of liver, kidney, heart and other important organs; 5.implanted pacemaker or metal plate in the skull; 6.inability to undergo a videofluoroscopic swallowing study (VFSS); 7.Individuals with severe visual or hearing impairments; 8.pregnant or lactating women; 9.situation of skull loss; 10.The researcher consider that there are any conditions that may harm the subjects or cause them to be unable to meet or perform the research requirements.

Design outcomes

Primary

MeasureTime frame
Rosenbek penetration-aspiration scale, PAS;video fluoroscopic images for swallowing;

Secondary

MeasureTime frame
Standardized Swallowing Assessment (SSA);Motion Evoked Potential (MEP), Resting Motor Threshold (RMT);functional near-infrared spectroscopy, fNIRS;Safety Assessment;Event-Related Potential, ERP;

Countries

China

Contacts

Public ContactHui Yanping

Xi'an Jiaotong University Second Affiliated Hospital

huiyanping@mail.xjtu.edu.cn+86 29 87679570

Outcome results

None listed

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