Status:
COMPLETED
Effects of Repetitive Transcranial Magnetic Stimulation on Patients With Dysphagia in Stroke Observed Based on Functional Near-infrared Spectroscopic
Lead Sponsor:
Ruyao Liu
Conditions:
Stroke
Deglutition Disorders
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15...
Detailed Description
Stroke is the leading cause of death and disability worldwide, and dysphagia is one of the common complications of stroke.Dysphagia after stroke can lead to serious complications such as aspiration, p...
Eligibility Criteria
Inclusion
- 18 to 80 years of age, right-handed;
- unilateral stroke, diagnosed by cranial MRI or CT;
- disease duration of 2 weeks to 6 months;
- dysphagia confirmed by the Videofluoroscopic swallowing study;
- patient's vital signs were stable;
- consciousness was clear, able to cooperate in completing the rehabilitation therapy, assessment, and the fNIRS test;
- cranial bone was intact without craniotomy and/or craniovertebral repair;
- the subject signed the Declaration of Helsinki according to the Informed consent.
Exclusion
- previous dysphagia due to other diseases such as Parkinson's disease, dementia, or the presence of organic swallowing dysfunction;
- contraindications to rTMS: stimulation coils or the presence of a metal foreign body near the stimulated scalp, built-in pulse generators, cardiac stents, cardiac bypass grafting, etc;
- previous history of psychiatric disease or epilepsy;
- pregnancy;
- skin infection or breakage on the head;
- previous or current stroke, traumatic brain injury and other neurological or mental system diseases;
- serious cardiac, pulmonary, hepatic, renal dysfunction, malignant tumors, serious complications;
- poor patient compliance and evaluation,other neurological or psychiatric disorders;
- severe cardiac, pulmonary, hepatic, or renal dysfunction, malignant tumors, and serious complications;
- poor patient compliance and non-cooperation with treatment and evaluation.
Key Trial Info
Start Date :
May 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06213597
Start Date
May 28 2023
End Date
January 8 2024
Last Update
January 24 2024
Active Locations (1)
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1
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan, China, 450000