Cerebral InfarctionIOE+JLCJ-SNCT06265779
Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia
A study testing Comprehensive rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding and Transcranial direct current stimulation in people with Cerebral Infarction, run by Zeng Changhao at 1 site in South Korea.
Trial summary
The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Comprehensive rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding and Transcranial direct current stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Feb 2024to 15 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for ischemic stroke confirmed by MRI or CT;
- Age > 18 years;
- First-time stroke;
- Swallowing disorder confirmed by swallowing contrast study or flexible endoscopic evaluation of swallowing;
- Requires enteral nutrition support;
- Stable vital signs, no severe cognitive impairment or aphasia, able to cooperate with treatment;
- Transferred to the rehabilitation department within fifteen days of onset;
- Stable vital signs.
Who cannot join
- Presence of contraindications for invasive oral endoscopy;
- Concurrent presence of other neurodegenerative diseases that may cause swallowing disorders, such as neurodegenerative diseases;
- Concurrent presence of other neurological disorders;
- Tracheostomized patients;
- Concurrent liver, kidney failure, tumor, or hematological disorders;
- Pregnancy;
- Presence of contraindications for transcranial direct current stimulation, such as epilepsy, cerebral edema;
- Recent use of centrally acting drugs that interfere with the effects of transcranial direct current stimulation, such as carbamazepine, phenytoin, valproic acid, etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Center Rehabilitation Hospital
Seoul
Wei Liu, Master
About this study
Official title: Therapeutic Effect of Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Feeding on Swallowing Disorders in Patients With Cerebral Infarction: Double Blind Randomized Controlled Study
The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
Read the detailed description
Transcranial direct current stimulation is currently very popular. The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
- Conditions
- Cerebral Infarction
- Being tested
- Comprehensive rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding, Transcranial direct current stimulation
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive rehabilitation therapyBehavioural
Including： Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
Intermittent Oro-esophageal Tube FeedingDevice
All patients are given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.
Transcranial direct current stimulationDevice
In this study, transcranial direct current stimulation is performed using a battery-powered constant current stimulator. This device delivers the current through two electrodes immersed in saline solution. Specifically, a 50mm*50mm anodal electrode pad is placed at the center of the healthy side swallowing sensory-motor cortex of the patient. According to the positioning method of the international 10-20 electrode system, the swallowing sensory-motor cortex of the left brain is located at the midpoint between C3 and T3, while that of the right brain is located at the midpoint between C4 and T4. The cathode is placed on the opposite shoulder, using a current of 1mA, once a day, for 20 minutes each time, and 5 days a week. The instruments used for placebo patients will not have any actual effect.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. Receives: Behavioral: Comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding; Device: Transcranial direct current stimulation |
| The placebo group | Placebo comparator | The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. Receives: Behavioral: Comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Aspiration Scale
Penetration-Aspiration Scale is used to measure swallowing safety, which is also the primary outcome of this study. Before and after treatment, patients are required to undergo a swallow study to complete the assessment. This scale evaluates the patient's swallowing function level and aspiration risk by assessing leakage and aspiration during the patient's swallowing process. The results are divided into eight levels, with higher levels indicating poorer swallowing function and lower swallowing safety.
Measured: day 1 and day 15
Secondary outcomes (6)
Functional Oral Intake Scale
During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted.
Measured: day 1 and day 15
Swallowing Quality of Life Questionnaire
The Swallowing Quality of Life Questionnaire (SWAL-QOL) is used to evaluate the impact of swallowing function on patients' quality of life. The questionnaire consists of 44 questions related to swallowing function and quality of life. Each question is answered using a 5-point rating scale. In this study, the final score is converted into a percentage. The higher scores indicate the better quality of life.
Measured: day 1 and day 15
Patient Health Questionnaire-9
To assess the patients' depression levels, a questionnaire is used. The questionnaire consists of 9 questions related to depressive symptoms, and each question is answered using a 4-point rating scale. The total score ranges from 0 to 27, with higher scores indicating a greater tendency towards depression.
Measured: day 1 and day 15
Body weight
Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.
Measured: day 1 and day 15
Nutritional status-total protein
The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.
Measured: day 1 and day 15
Nutritional status-albumin
The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning
Measured: day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start29 Feb 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Principal investigator, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265779
- Sponsor's protocol ID
- 2024-KY-0122
- Acronym
- IOE+JLCJ-S
- Status last verified
- Mar 2024
- First submitted
- 22 Jan 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Feeding on Swallowing Disorders in Patients With Cerebral Infarction: Double Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06265779
- Acronym / sponsor ID
- IOE+JLCJ-S / 2024-KY-0122
- Conditions
- Cerebral Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
Detailed description
Transcranial direct current stimulation is currently very popular. The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Behavioral: Comprehensive rehabilitation therapy, Device: Intermittent Oro-esophageal Tube Feeding, Device: Transcranial direct current stimulationThe patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. |
| The placebo group | Placebo comparator | Behavioral: Comprehensive rehabilitation therapy, Device: Intermittent Oro-esophageal Tube FeedingThe patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the diagnostic criteria for ischemic stroke confirmed by MRI or CT;
- Age > 18 years;
- First-time stroke;
- Swallowing disorder confirmed by swallowing contrast study or flexible endoscopic evaluation of swallowing;
- Requires enteral nutrition support;
Key exclusion criteria (8 listed)
- Presence of contraindications for invasive oral endoscopy;
- Concurrent presence of other neurodegenerative diseases that may cause swallowing disorders, such as neurodegenerative diseases;
- Concurrent presence of other neurological disorders;
- Tracheostomized patients;
- Concurrent liver, kidney failure, tumor, or hematological disorders;
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 |
|---|---|---|
| Comprehensive rehabilitation therapyIncluding： Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. | Behavioural | The experimental group, The placebo group |
| Intermittent Oro-esophageal Tube FeedingAll patients are given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding. | Device | The experimental group, The placebo group |
| Transcranial direct current stimulationIn this study, transcranial direct current stimulation is performed using a battery-powered constant current stimulator. This device delivers the current through two electrodes immersed in saline solution. Specifically, a 50mm*50mm anodal electrode pad is placed at the center of the healthy side swallowing sensory-motor cortex of the patient. According to the positioning method of the international 10-20 electrode system, the swallowing sensory-motor cortex of the left brain is located at the midpoint between C3 and T3, while that of the right brain is located at the midpoint between C4 and T4. The cathode is placed on the opposite shoulder, using a current of 1mA, once a day, for 20 minutes each time, and 5 days a week. The instruments used for placebo patients will not have any actual effect. | Device | The experimental group |
Primary outcome
Penetration Aspiration Scale
Time frame: day 1 and day 15
Penetration-Aspiration Scale is used to measure swallowing safety, which is also the primary outcome of this study. Before and after treatment, patients are required to undergo a swallow study to complete the assessment. This scale evaluates the patient's swallowing function level and aspiration risk by assessing leakage and aspiration during the patient's swallowing process. The results are divided into eight levels, with higher levels indicating poorer swallowing function and lower swallowing safety.
6 secondary outcomes
Functional Oral Intake Scale
Time frame: day 1 and day 15
Swallowing Quality of Life Questionnaire
Time frame: day 1 and day 15
Patient Health Questionnaire-9
Time frame: day 1 and day 15
Body weight
Time frame: day 1 and day 15
Nutritional status-total protein
Time frame: day 1 and day 15
Nutritional status-albumin
Time frame: day 1 and day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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.
Nieto Luis, Master principal investigator
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding and Transcranial direct current stimulation in people with Cerebral Infarction, run by Zeng Changhao at 1 site in South Korea.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhefeng Wang, Master (19501376864, zhengzhouzhj@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (time frame: day 1 and day 15). 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 6 Mar 2024.