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Completed

NCT Number: NCT06852040

Effect of TDCS Combined with Intraoral Electrical Stimulation

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.

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Key information

Age range

1 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Handan Central Hospital

Handan, Hebei, 057150, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoral induction electrical stimulation therapy

Device

Intraoral induction electrical stimulation therapy (specific method[13]: hand-held electrode rods were used to stimulate the mandibular hyoid muscle, digastric muscle, anterior abdomen, and other muscles of the three groups. Parameter setting: the frequency is 80Hz, the wave width is 1ms, the intensity is set to the muscle contraction, each electrical stimulation is 3s, intermittent 10s, 20min/time, 1 time/day, 5 days/week, 4 weeks is limited.

tDCS treatment

Device

tDCS treatment (specific method: microcurrent stimulator, stimulation electrode (3 cm×4 cm gelatin sponge), anodic stimulation site is the pharyngeal sensorimotor cortex area (between C3/T3 on the left[14], between C4/T4 on the right); the supraorbital area is the site of cathodic stimulation. The direct current intensity is 2.0 mA (20 min/time, 2 times/day) for two treatments (respectively, yin and yang alternating treatment), with an interval of at least 1 h, 5 days/week, and 4 weeks.

tDCS combined with intraoral induction electrical stimulation

Device

tDCS combined with intraoral induction electrical stimulation. The patients were first treated with tDCS (the method is the same as that of the control group B) for 20 people twice a day and then given intraoral induction stimulation (the specific method is the same as that of the control group A) for 20 minutes, once a day, for 4 weeks.

Primary outcomes

  1. MWST

    Time frame: 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%.

  2. FOIS

    Time frame: 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.

  3. RAS

    Time frame: 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.

  4. Hyoid laryngeal complex mobility

    Time frame: 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.

  5. Maximum Amplitude and Swallowing Time of Surface Electromyography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xuehai Lv

Other

Registry information

Official study title

Analysis of the Therapeutic Effect of TDCS Combined with Intraoral Electrical Stimulation on Dysphagia After Pontine Infarction

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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