Pontine InfarctionNCT06852040
Effect of TDCS Combined with Intraoral Electrical Stimulation
A study testing Intraoral induction electrical stimulation therapy, tDCS treatment and tDCS combined with intraoral induction electrical stimulation in people with Pontine Infarction, run by Xuehai Lv at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Pontine Infarction
- What is being tested?
- Intraoral induction electrical stimulation therapy, tDCS treatment and tDCS combined with intraoral induction electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Therapeutic Effect of TDCS Combined with Intraoral Electrical Stimulation on Dysphagia After Pontine Infarction
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.
- Conditions
- Pontine Infarction
- Being tested
- Intraoral induction electrical stimulation therapy, tDCS treatment, tDCS combined with intraoral induction electrical stimulation
- Keywords
- pontine infarction, dysphagia, transcranial direct current stimulation, Inductive electrical stimulation in the mouth
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral induction electrical stimulation therapyDevice
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 treatmentDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| control group A | Active comparator | 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. Receives: Device: Intraoral induction electrical stimulation therapy |
| control group B | Active comparator | 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. Receives: Device: tDCS treatment |
| experimental group C | Experimental | 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. Receives: Device: tDCS combined with intraoral induction electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MWST
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%.
Measured: 4 weeks
FOIS
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.
Measured: 4 weeks
RAS
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.
Measured: 4 weeks
Hyoid laryngeal complex mobility
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.
Measured: 4 weeks
Maximum Amplitude and Swallowing Time of Surface Electromyography
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Oct 2022
- Primary completion1 Nov 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pontine InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuehai Lv
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuehai Lv, Handan Central Hospital
- Investigators
- Xuehai Lv Lv, Principal investigator, Handan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852040
- Sponsor's protocol ID
- HandanCentral001
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Therapeutic Effect of TDCS Combined with Intraoral Electrical Stimulation on Dysphagia After Pontine Infarction
- ClinicalTrials.gov ID
- NCT06852040
- Acronym / sponsor ID
- HandanCentral001
- Conditions
- Pontine Infarction
- Keywords
- pontine infarction, dysphagia, transcranial direct current stimulation, Inductive electrical stimulation in the mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Xuehai LvUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group A | Active comparator | Device: Intraoral induction electrical stimulation therapyA 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. |
| control group B | Active comparator | Device: tDCS treatmenttDCS 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 | Experimental | Device: tDCS combined with intraoral induction electrical stimulationtDCS 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. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral induction electrical stimulation therapyIntraoral 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. | Device | control group A |
| tDCS treatmenttDCS 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. | Device | control group B |
| tDCS combined with intraoral induction electrical stimulationtDCS 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. | Device | experimental group C |
Primary outcome
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%.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuehai Lv Lv principal investigator
Handan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral induction electrical stimulation therapy, tDCS treatment and tDCS combined with intraoral induction electrical stimulation in people with Pontine Infarction, run by Xuehai Lv at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MWST (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.