NCT06213597Completed
Effects of Repetitive Transcranial Magnetic Stimulation on Patients With Dysphagia in Stroke Observed Based on Functional Near-infrared Spectroscopic
Effects of Healthy-side High-frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke Dysphagia: a Prospective Study Based on Functional Near-infrared Spectroscopic
Source: ClinicalTrials.gov · Last updated 24 Jan 2024
Brief summary (registry, in English)
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) or sham rTMS group (n=15). Both groups received conventional swallowing rehabilitation, and in addition, the rTMS group received 5hz repetitive transcranial magnetic stimulation on the healthy side. Swallowing function was assessed at admission and after two weeks of treatment using the the Standardized Swallowing Assessment (SSA), the Penetration-Aspiration Scale (PAS), the Fiberoptic Endoscopic Dysphagia Severity Scale(FEDSS), the Functional Oral Intake Scale (FOIS), and the functional near-infrared spectroscopic(fNIRS).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 10 Jan 2024
- Start date
- 28 May 2023
- Primary completion date
- 25 Dec 2023
- Lead sponsor
- Ruyao Liu
- Diseases
- Stroke
- NCT number
- NCT06213597
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 28 May 2023 to the primary completion date, 25 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous dysphagia due to other diseases such as Parkinson's disease, dementia, or the presence of organic swallowing dysfunction;
- previous history of psychiatric disease or epilepsy;
- previous or current stroke, traumatic brain injury and other neurological or mental system diseases;
Other illness
- 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;
- skin infection or breakage on the head;
- 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;
Other
- pregnancy;
- poor patient compliance and non-cooperation with treatment and evaluation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.