Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia

NCT06265779 | Recruiting DMC

• 1 other identifier: 2024-KY-0122
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1 and day 15

Secondary Outcomes (6)

• Functional Oral Intake Scale

  day 1 and day 15

• Swallowing Quality of Life Questionnaire

  day 1 and day 15

• Patient Health Questionnaire-9

  day 1 and day 15

• Body weight

  day 1 and day 15

• Nutritional status-total protein

  day 1 and day 15

Study Arms (2)

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.

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.

Behavioral: Comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding

Interventions

Comprehensive rehabilitation therapy BEHAVIORAL

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.

The experimental group; The placebo group

Intermittent Oro-esophageal Tube Feeding DEVICE

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.

The experimental group; The placebo group

Transcranial direct current stimulation DEVICE

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.

The experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Center Rehabilitation Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhefeng Wang, Master

CONTACT

19501376864; zhengzhouzhj@qq.com

Weijia Zhao, Master

CONTACT

17839973473; zwjww2009@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 20, 2024
• Study Start: February 29, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 15, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)