Effect of TDCS Combined with Intraoral Electrical Stimulation

Not Applicable

Completed

• Conditions: Pontine Infarction

• Registration Number: NCT06852040
• Lead Sponsor: Xuehai Lv

Brief Summary

Objective: To investigate the clinical efficacy of transcranial direct current stimulation (tDCS) combined with intraoral electrical stimulation in patients with dysphagia after pontine infarction. Methods: This prospective study enrolled a total of 90 patients with dysphagia due to pontine infarction from October 2022 to November 2024, and they were divided into three groups according to the treatment method: control group A, control group B, and experimental group C. Control group A was given intraoral induction electrical stimulation, control group B was given transcranial direct current stimulation (tDCS), and experimental group C was given tDCS combined with intraoral induction electrical stimulation. The three groups were compared in terms of efficacy, modified Waffield Drinking Water Test Score (MWST), Penetration-aspiration scale (PAS), Functional Oral Intake Scale (FOIS), Hyoid-Larynx Complex mobility, maximum amplitude of surface electromyography, and swallowing time.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2024-11-01
• Study Completion: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with dysphagia (able to cooperate with swallowing assessment) and consistent with the criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"[9] or pontine infarction by clinical imaging examination;
• Age≥18 years or ≤80 years;
• The modified water swallow test (MWST) score is 3-5[10] or the Functional Oral Intake Scale score <4

Exclusion Criteria

• Those who are intolerant to electrical stimulation or allergic to auxiliary electrodes;
• Patients with implanted pacemakers, metal stents in the neck, or other reasons that cannot be treated with electrical stimulation;
• Patients who are critically ill or unable to cooperate with the assessment and treatment of patients with dysphagia due to other reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MWST	4 weeks	The patient was instructed to stay in a Sitting or standing position, drink 1 ml, 3 ml, and 5 ml of water, respectively, and drink 30 ml of water when the patient did not show abnormal manifestations. The severity of dysphagia is classified as 1-5 according to the time the patient drinks water, whether there is choking, swallowing in fractions, etc., and the lower the rating, the better the swallowing function. (1) significantly effective: the MWST assessment reached grade 1 or decreased ≥ grade 2. (2) Effective: MWST assessment is reduced by 1 level. (3) Ineffective: There is no change before and after the MWST assessment. Total effective rate = (significant effect + effective) number of cases/total number x 100%.
FOIS	4 weeks	The patient's oral feeding function is according to the type of food and the way the patient eats. 1 point: No oral food at all; 2 points: Dependent on tube feeding, can try to eat the smallest amount; 3 points: 3 points: tube feeding, oral ingestion of food or liquid of single quality；4 points: Completely oral consumption of a single quality of food; 5 points: Completely oral consumption of a variety of food qualities, but special preparation or compensation is required; 6 points: Eat completely by mouth, but with special food restrictions; 7 points: No restriction on complete oral feeding, The score is directly proportional to the swallowing function.
RAS	4 weeks	1 point, the bolus does not enter the airway; 2 points, the bolus enters the airway, is above the level of the vocal cords, and is ejected from the airway; 3 points, the bolus enters the airway, is above the level of the vocal cords, and is not ejected from the airway; At 4 minutes, the bolus enters the airway and is ejected from the airway; 5 points, the bolus enters the airway, but does not eject from the airway; 6 points, the substance enters the airway, reaches below the level of the vocal cords, and is ejected into the larynx or outside the airway; At 7 minutes, the bolus enters the airway and reaches below the level of the vocal cords, but the force is still not ejected from the trachea; At 8 points, the bolus enters the airway, reaches below the level of the vocal cords, and is unable to eject. PAS was assessed according to the Videofluoroscopy Swallowing Study (VFSS) or Point-of-Care Fiberoptic Endoscopic Swallowing.
Hyoid laryngeal complex mobility	4 weeks	X-ray recording of the upward and anterior displacement of the hyoid bone and thyroid cartilage during swallowing. After 4 weeks of treatment, the dynamic (swallowing state), the static hyoid bone, and thyroid cartilage positions, and the dynamic and static differences of thyroid cartilage and hyoid bone in the vertical and horizontal directions were recorded as the upward distance and forward distance, respectively.
Maximum Amplitude and Swallowing Time of Surface Electromyography	4 weeks	Maximum Amplitude: This refers to the highest voltage peak recorded by the electromyography (EMG) analyzer during the swallowing process. It is an indicator of the strength of muscle activation involved in swallowing. Higher maximum amplitudes suggest stronger muscle contractions and potentially better swallowing function.Swallowing Time: This is the duration, measured in seconds, from the onset of the swallowing action (initiated by the movement of the tongue) to the completion of the bolus passing through the pharynx and entering the esophagus. Shorter swallowing times are generally associated with more efficient swallowing mechanics and reduced risk of aspiration.

Trial Locations

Locations (1)

Handan Central Hospital; 🇨🇳 Handan City, Hebei, China