UMIN ID: UMIN000053913
Registered date:20/03/2024
Examination of changes in swallowing and articulation-related brain activity in patients after head and neck cancer surgery
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | head and neck cancer |
| Date of first enrollment | 2024/07/06 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Electroencephalography (EEG) measurements will be taken six months after surgery for head and neck cancer. The EEG will be used to calculate the amplitude (power) during swallowing and articulatory movements. The power of the EEG is considered to be related to the activity level of brain neurons. |
|---|---|
| Secondary Outcome | 1. Evaluation of Aspiration and Pharyngeal Residue with Food: The Aspiration-Residue (AsR) score, as referenced in the literature, will be utilized to evaluate aspiration and pharyngeal residue during videofluoroscopic swallowing studies (VFSS) with food. This is a simplified evaluation method for VFSS after treatment for head and neck cancer. It quantifies the degree of aspiration ("As" for aspiration) and pharyngeal residue ("R" for residual) on a scale of up to 10 points, with lower scores indicating more severe dysphagia. 2. Speech Clarity: Articulatory function will be evaluated on a 5-point scale, where 1 represents clear speech, 2 indicates occasional unintelligible words, 3 suggests the listener can understand if they are familiar with the topic, 4 means only occasional words are understandable, and 5 indicates completely incomprehensible speech. |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Presence of cognitive impairments that make it difficult to understand explanations or instructions. 2. History of neurological disorders. 3. Individuals currently undergoing treatment for recurrence or metastasis in the head and neck area. 4. Post-operative head and neck cancer patients who have not undergone laryngectomy or free flap reconstruction surgery. |
Related Information
| Primary Sponsor | Kyoto University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kodama foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Atsushi Suehiro |
| Address | 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto, Japan Japan 606-8507 |
| Telephone | 075-751-3346 |
| a_suehiro@ent.kuhp.kyoto-u.ac.jp | |
| Affiliation | Graduate School of Medicine, Kyoto University Department of Otolaryngology, Head & Neck Surgery |
| scientific contact | |
| Name | Atsushi Suehiro |
| Address | 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto, Japan Japan |
| Telephone | 075-751-3346 |
| a_suehiro@ent.kuhp.kyoto-u.ac.jp | |
| Affiliation | Graduate School of Medicine, Kyoto University Department of Otolaryngology, Head & Neck Surgery |