Skip to content

A randomized controlled trial to investigate the effect of combined swallowing therapy program and tDCS on improving feeding and swallowing function in perioperative patients with tongue cancer

A randomized controlled trial to investigate the effect of combined swallowing therapy program and tDCS on improving feeding and swallowing function in perioperative patients with tongue cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042250062
Enrollment
22
Registered
2025-07-11
Start date
2025-11-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tongue cancer Tongue cancer

Interventions

This stimulation group: Transcranial direct current electrical stimulation of the primary motor cortex by tDCS will be performed at 1.5 mA for 5 consecutive days for 10 minutes until the discontinuati
Tongue cancer, tDCS

Sponsors

Okamoto Hideki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1 (at the time of first-stage enrollment) 1. Patients with a confirmed diagnosis of tongue cancer (stage II-IVA) and who are eligible for surgery. 2. Age 20-85 years old. 3. General condition: Performance Status (PS) 1-2 (ECOG). 4. Written informed consent for participation in this study has been obtained from the subject or their legal representative. Inclusion Criteria 2 (at the time of second-stage enrollment) 1. Patients with stable general condition and surgical wounds after surgery for stage II-IVA tongue cancer. 2. Patients who have undergone neck dissection and whose intact lateral tongue molars, tongue base, and intact lateral tongue muscles remain after resection of the primary tumor.

Exclusion criteria

Exclusion criteria: Exclusion Criterion 1 (at the time of first-stage registration) 1. Individuals with stage 0, I, or stage IVB-C tongue cancer 2. Among patients with stage II tongue cancer, those who only undergo partial resection of the tongue without reconstruction after removal of the primary lesion 3. Individuals with a history or complications of other psychiatric or neurological disorders (including regular prescriptions for tranquilizers or antidepressants and on-demand or internal use of psychotropic medications) 4. Individuals with metal inside the skull (excluding titanium cranial plates less than 1mm and dental fillings) 5. Individuals equipped with medical pumps or cardiac pacemakers 6. Individuals with a history of epilepsy 7. Individuals classified as clinical severity level 1 or below for dementia, cerebrovascular disease, postoperative occlusal disorder, or eating and swallowing disorders 8. Individuals with comorbidities of cardiovascular or respiratory diseases such as myocardial infarction, angina, hypertension (systolic blood pressure 200/diastolic blood pressure 120 mmHg or higher), deep vein thrombosis, chronic respiratory failure, posing a risk for exercise 9. Individuals with significant hearing impairment who cannot communicate 10. Pregnant individuals, or those who may become pregnant during the study period 11. Individuals with a history of contrast agent allergy 12. Individuals deemed ineligible based on referencing medical records or referral letters concerning the pre-checklist of transcutaneous electrical stimulation 13. Other individuals deemed inappropriate by the research principal or co-investigator. Exclusion Criteria 2 (Second-Stage Enrollment) 1. Patients with postoperative delirium, dementia, or other psychiatric disorders who are unable to receive adequate treatment are excluded. 2. Patients with poor postoperative general condition or other complications who are unable to receive adequate treatment are excluded. 3. Patients who underwent laryngeal lift surgery after primary tumor resection are excluded.

Design outcomes

Primary

MeasureTime frame
1.MBSImP (Modified Barium Dysphagia Profile) 2.Measurement of tongue pressure using the tongue pressure measuring device (TPM-02E)

Secondary

MeasureTime frame
Dysphagia Severity Scale, Functional oral intake scale, Hyodo Score,VF video analysis using 2D analysis software

Contacts

Public ContactHideki Okamoto

Nagoya City University

yands53okamoto@yahoo.co.jp+81-52-853-8733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026