Trials / Enrolling By Invitation

Enrolling By InvitationNCT06464835

Effects of ITBS Combined with NMES on Dysphagia After Stroke

Effect of ITBS Combined with NMES on Post-stroke Dysphagia and Corresponding Neural Network

Status: Enrolling By Invitation
Phase: N/A
Study type: Interventional
Enrollment: 45 (estimated)

Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

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) .

Detailed description

The purpose of this study is to observe the effect of intermittent Theta Burst Stimulation (iTBS) combined with neuromuscular electrical stimulation (NMES) on patients with dysphagia (PSD) after stroke, and to detect the activation of related swallowing networks in patients with PSD after receiving iTBS combined with NMES by functional near-infrared spectroscopy (fNIRS), and to explore the possible mechanism of PSD treatment, so as to provide a theoretical basis for finding the best, specific and individualized treatment plan for the treatment of PSD patients. Promote the functional recovery of patients, reduce complications, and promote the prognosis of diseases. Patients who withdrew treatment for any reason other than progression (other than withdrawal of consent or loss to follow-up) continued to undergo objective assessment every 8 weeks to collect information on disease progression. Investigators were required to collect long-term follow-up information on survival by telephone at least every 12 weeks after documentation of disease progression by contacting patients, family members, or the patient's current treating physician. Subjects who have the right to withdraw from the trial in the middle of the trial, or who are no longer tested and are lost to follow-up even though they have not explicitly proposed to withdraw from the trial, are also considered "withdrawal" (or "dropout"). The reasons for their withdrawal should be known as much as possible and documented. If the withdrawal is due to an adverse event, the patient should be visited for examination until the pre-treatment status or no clinical significance, and the adverse event form should be completed. The cause of the absconted case should be recorded in detail, and the informed consent form, original medical record, and case report form should be retained for future reference. Treatment of drop-off cases: (1) When the subject falls off, the investigator should contact the subject to inquire about the reason as much as possible by visiting the door to make an appointment by telephone or letter. (2) If the experimental case is withdrawn due to allergic reactions, adverse reactions, or ineffective treatment, the investigator shall take corresponding treatment measures according to the actual situation of the subject. (3) The investigator should fill in the record of the main reason for discontinuing the trial. (4) All patients who have been selected and have been numbered, regardless of whether they have dropped out or not, should be recorded and kept for observation, both for filing and for intention-to-intention analysis (ITT), and all shedding cases should be summarized and statistically analyzed. The sample size was calculated using G-power software based on the references.SPSS software was used for statistical description and analysis. Count data were expressed as rates or percentages, and chi-square tests were used for comparisons between groups. If the data conform to the normal distribution and the variance is homogeneous, (x̅ ± s) is used to express the continuous data, the one-way ANOVA was used for comparison between multiple groups, the least-significant difference (LSD) method was used for subsequent pairwise comparisons, and the paired sample t-test was used for comparison before and after treatment within the group. If the normal distribution is not conformed, the median and quartile M(P25,P75) are used, and the rank sum test is used. A P value of less than 0.05 indicated that the difference was statistically significant. The task state data processing of （functional near-infrared spectroscopy，fNIRS） is run by NirSpark toolkit software for data preprocessing. is run by NirSpark toolkit software for data preprocessing.

Conditions

Interventions

Type	Name	Description
DEVICE	Transcranial magnetic stimulation	The treatment parameter for iTBS was 80% stimulus intensity. The stimulation frequency was 50Hz in the plexus and 5Hz in the interplexus. Each burst stimulus consisted of 3 consecutive pulses, 2s stimulus, 8s interval, and repeated 20 times, a total of 600 pulses, and the duration of stimulation was 189s. NMES treatment parameters for output waveform for two-way square wave, wave width 700 ms, positive and negative half wave (300 ms) between 100 ms intermittent, stimulating frequency 50 hz, treatment when the output intensity range of 0 \~ 25 ma, stimulating electrodes pasted in bilateral mandibular hyoid muscle movement points, output intensity in patients with tongue bone muscle group it is advisable to have a sense of fashion, extrusion. Each treatment lasted 30 minutes, once a day, 5 times a week for 2 weeks.

Timeline

Start date: 2024-08-03
Primary completion: 2025-11-01
Completion: 2025-12-01
First posted: 2024-06-18
Last updated: 2024-09-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06464835. Inclusion in this directory is not an endorsement.