Effects of ITBS Combined with NMES on Dysphagia After Stroke

NCT06464835 | Enrolling By Invitation

• 1 other identifier: 2024-6-11
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (3)

• functional near-infrared spectroscopy

  Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technology based on blood vessels, which can be used to evaluate the activation of brain regions associated with swallowing

  immediately before and immediately after the intervention

• Standardized Swallowing Assessment Scale

  The Standard Swallowing Assessment Scale is a method of assessing a patient's swallowing function. During the assessment, the patient's level of consciousness, head and trunk control, breathing patterns, lip closure, soft palate movements, laryngeal function, gag reflex, and voluntary cough should be recorded.The highest score on the scale is 46 points, and the lowest score is 18 points, and the lower the score, the better the swallowing function.

  immediately before and immediately after the intervention

• The Yale Pharyngeal Residue Severity Rating Scale

  The Yale Pharyngeal Residue Severity Rating Scale is a laryngoscopy-based assessment scale used to assess the degree of food residue.The scale divided the residues of the valley of the eglottis and the piriform fossa into grades 1-5 according to the severity of the scale, respectively. The higher the grade, the more severe the food residue

  immediately before and immediately after the intervention

Study Arms (3)

iTBS combined with NMES

EXPERIMENTAL

On the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with iTBS first, followed by NMES stimulation for 30 minutes after 10 minutes

Device: Transcranial magnetic stimulation

iTBS combined with sham NMES

EXPERIMENTAL

On the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with iTBS first, followed by NMES sham stimulation for 30 minutes after 10 minutes

Device: Transcranial magnetic stimulation

sham iTBS combined with NMES

EXPERIMENTAL

On the basis of conventional treatment and swallowing rehabilitation training,The swallowing cortex of the affected hemisphere was stimulated with sham iTBS first, followed by NMES stimulation for 30 minutes after 10 minutes

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation DEVICE

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.

iTBS combined with NMES; iTBS combined with sham NMES; sham iTBS combined with NMES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450044, China

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 18, 2024
• Study Start: August 3, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)