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Effects of ITBS Combined with NMES on Dysphagia After Stroke

NCT06464835 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-09-27

No results posted yet for this study

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) .

Conditions

  • Stroke
  • Dysphagia
  • Intermittent Theta Burst Stimulation
  • Neuromuscular Electrical Stimulation
  • Functional Near-infrared Spectroscopy

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-03
Primary Completion
2025-11-01
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06464835 on ClinicalTrials.gov