Effect of TDCS Combined with Intraoral Electrical Stimulation
NCT ID: NCT06852040
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2022-10-01
2025-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
DOUBLE
Study Groups
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control group A
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.
Intraoral induction electrical stimulation therapy
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.
control group B
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 treatment
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.
experimental group C
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.
tDCS combined with intraoral induction electrical stimulation
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.
Interventions
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tDCS treatment
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.
Intraoral induction electrical stimulation therapy
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 combined with intraoral induction electrical stimulation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
80 Years
ALL
No
Sponsors
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Xuehai Lv
OTHER
Responsible Party
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Xuehai Lv
Associate Chief Physician
Principal Investigators
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Xuehai Lv Lv
Role: PRINCIPAL_INVESTIGATOR
Handan Central Hospital
Locations
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Handan Central Hospital
Handan, Hebei, China
Countries
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Other Identifiers
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HandanCentral001
Identifier Type: -
Identifier Source: org_study_id
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