Effects of ITBS Combined with NMES on Dysphagia After Stroke (NCT06464835) | Clinical Trial Compass
By InvitationNot Applicable
Effects of ITBS Combined with NMES on Dysphagia After Stroke
China45 participantsStarted 2024-08-03
Plain-language summary
In recent years, research on intermittent Theta Burst Stimulation (iTBS), as a special high-frequency (repetitive transcranial magnetic stimulation,rTMS) stimulation paradigm, has focused on exploring the effects in healthy people. Based on previous studies, it is believed that the central magnetic stimulation combined with peripheral electrical stimulation based on the "central-peripheral-central" closed-loop rehabilitation concept has the best effect, but there are few clinical studies on the efficacy and mechanism of iTBS combined treatment of dysphagia after stroke, and the selection of the optimal stimulation scheme and target has not yet been determined, therefore, this study aims to observe the efficacy and mechanism of implementation of iTBS combined with neuromuscular electrical stimulation (NMES) on with patients with dysphagia (PSD) .
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 \~80 years old;
* The patients met the diagnostic criteria of stroke in the "Diagnostic Points for Major Cerebrovascular Diseases in China 2019" formulated by the Chinese Society of Neurology, and were confirmed by head CT or MRI;
* The patients met the diagnostic criteria of dysphagia in the "Chinese Expert Consensus on the Evaluation and treatment of Dysphagia (2017 edition)" and were confirmed by VFSS;
* The disease duration ranged from 2 weeks to 6 months;
* The vital signs of the patient were stable;
* The score of mini-mental state examination (MMSE) was more than 17 points for the illiterate, more than 20 points for the primary scholar, and more than 24 points for the secondary school or above;
* Can independently or under the auxiliary balance the seat 30 minutes or more;
* The skull was intact without craniotomy and/or cranioplasty;
* Informed consent was obtained from all subjects or their families.
Exclusion Criteria:
* A history of other diseases that may cause dysphagia, such as Parkinson's disease, head and neck radiotherapy, or other neurological diseases;
* Contraindications to iTBS or NMES with a history of epilepsy, intracranial metal implants, bleeding tendency, etc.;
* Skin damage and infection on the front of the neck affect the placement of the surface electrode;
* Such as fever, important viscera function failure condition is not stable, or critically ill.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
functional near-infrared spectroscopy
Timeframe: immediately before and immediately after the intervention
2
Standardized Swallowing Assessment Scale
Timeframe: immediately before and immediately after the intervention
3
The Yale Pharyngeal Residue Severity Rating Scale
Timeframe: immediately before and immediately after the intervention
Trial details
NCT IDNCT06464835
SponsorThe First Affiliated Hospital of Zhengzhou University