## Protocol Section
### Identification Module
**NCT ID:** NCT06265779

**Acronym:** IOE+JLCJ-S

**Brief Title:** Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia

**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

#### Organization Study ID Info
**ID:** 2024-KY-0122
#### Organization
**Class:** OTHER
**Full Name:** People's Hospital of Zhengzhou University
### Status Module
#### Completion Date
**Date:** 2024-12-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-02

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-29

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-02-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-22
**Study First Submit QC Date:** 2024-02-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zeng Changhao

#### Responsible Party

**Investigator Affiliation:** People's Hospital of Zhengzhou University

**Investigator Full Name:** Zeng Changhao

**Investigator Title:** Research Director

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Cerebral Infarction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 84

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Comprehensive rehabilitation therapy

- Device: Intermittent Oro-esophageal Tube Feeding

- Device: Transcranial direct current stimulation

**Label:** The experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Comprehensive rehabilitation therapy

- Device: Intermittent Oro-esophageal Tube Feeding

**Label:** The placebo group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- The experimental group

- The placebo group

**Description:** 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.

**Name:** Comprehensive rehabilitation therapy

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- The experimental group

- The placebo group

**Description:** 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.

**Name:** Intermittent Oro-esophageal Tube Feeding

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- The experimental group

**Description:** 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.

**Name:** Transcranial direct current stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Penetration Aspiration Scale

**Time Frame:** day 1 and day 15

#### Secondary Outcomes

**Description:** 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.

**Measure:** Functional Oral Intake Scale

**Time Frame:** day 1 and day 15

**Description:** 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.

**Measure:** Swallowing Quality of Life Questionnaire

**Time Frame:** day 1 and day 15

**Description:** 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.

**Measure:** Patient Health Questionnaire-9

**Time Frame:** day 1 and day 15

**Description:** Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.

**Measure:** Body weight

**Time Frame:** day 1 and day 15

**Description:** 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.

**Measure:** Nutritional status-total protein

**Time Frame:** day 1 and day 15

**Description:** 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

**Measure:** Nutritional status-albumin

**Time Frame:** day 1 and day 15

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhengzhouzhj@qq.com

**Name:** Zhefeng Wang, Master

**Phone:** 19501376864

**Role:** CONTACT

**Contact 2:**

**Email:** zwjww2009@163.com

**Name:** Weijia Zhao, Master

**Phone:** 17839973473

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Wei Liu, Master

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Center Rehabilitation Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Site Coordinator of United Medical Group located in Miami

**Name:** Nieto Luis, Master

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000020520

- Term: Brain Infarction

- ID: D000002545

- Term: Brain Ischemia

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020521

- Term: Stroke

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M5793

- Name: Cerebral Infarction

- Relevance: HIGH

- As Found: Cerebral Infarction

- ID: M10282

- Name: Infarction

- Relevance: HIGH

- As Found: Infarction

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M22305

- Name: Brain Infarction

- Relevance: LOW

- As Found: Unknown

- ID: M5794

- Name: Brain Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002544

- Term: Cerebral Infarction

- ID: D000007238

- Term: Infarction

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Removed Countries

- Country: China

- Version Holder: 2024-05-24
