Effect of TDCS Combined with Intraoral Electrical Stimulation

Xuehai Lv

Status: Completed

Conditions: Pontine Infarction

Treatments: Device: tDCS combined with intraoral induction electrical stimulation; Device: tDCS treatment; Device: Intraoral induction electrical stimulation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06852040

HandanCentral001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 1 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

control group A

Active Comparator group

Description:

A Swallowing neuromuscular electrical stimulator (LGT-2350A) from Guangzhou Longzhijie Medical Equipment Co., Ltd. was used. The electrodes are arranged sequentially on either side of the anterior midline of the neck. The parameter-selected electrical stimulation frequency is 80 Hz\[12\] (bidirectional square wave, pulse wave 300 microseconds, current intensity 10 to 25 mA） for 20 minutes each time, 1 time per day, 5 days/week, 4 weeks of treatment. which are limited to 20 min/time, 1 time/day, 5 days/week, and 4 weeks, respectively.

Treatment:

Device: Intraoral induction electrical stimulation therapy

control group B

Active Comparator group

Description:

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.

Treatment:

Device: tDCS treatment

experimental group C

Experimental group

Description:

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.

Treatment:

Device: tDCS combined with intraoral induction electrical stimulation