Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464835
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-18
First Post:
2024-06-11
Brief Title:
Effects of ITBS Combined with NMES on Dysphagia After Stroke
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
Effect of ITBS Combined with NMES on Post-stroke Dysphagia and Corresponding Neural Network
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent years research on intermittent Theta Burst Stimulation iTBS as a special high-frequency repetitive transcranial magnetic stimulationrTMS 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 patients 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 referencesSPSS 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 x 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 MP25P75 are used and the rank sum test is used A P value of less than 005 indicated that the difference was statistically significant The task state data processing of functional near-infrared spectroscopyfNIRS is run by NirSpark toolkit software for data preprocessing is run by NirSpark toolkit software for data preprocessing
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 patients 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 referencesSPSS 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 x 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 MP25P75 are used and the rank sum test is used A P value of less than 005 indicated that the difference was statistically significant The task state data processing of functional near-infrared spectroscopyfNIRS is run by NirSpark toolkit software for data preprocessing is run by NirSpark toolkit software for data preprocessing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None