UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053913 |
|---|---|
| Receipt number | R000061542 |
| Scientific Title | Examination of changes in swallowing and articulation-related brain activity in patients after head and neck cancer surgery |
| Date of disclosure of the study information | 2024/03/20 |
| Last modified on | 2024/03/20 13:15:12 |
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Basic information
Public title
Examination of changes in swallowing and articulation-related brain activity in patients after head and neck cancer surgery
Acronym
Examination of changes in swallowing and articulation-related brain activity in patients after head and neck cancer surgery
Scientific Title
Examination of changes in swallowing and articulation-related brain activity in patients after head and neck cancer surgery
Scientific Title:Acronym
Examination of changes in swallowing and articulation-related brain activity in patients after head and neck cancer surgery
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine brain activity in patients who have undergone surgery for head and neck cancer when performing swallowing and articulatory movements, to determine whether there are any changes in brain activity, and to ascertain if there are any commonalities depending on the type of surgery performed. Previous research has already established that brain activity during swallowing in healthy individuals can be detected through electroencephalography (EEG), providing a foundational understanding. Initially, EEG measurements will be conducted for each group of cases. The study aims to measure brain activity during swallowing, imagining swallowing, and during articulatory movement in post-operative patients using EEG, and to examine how brain activity changes.
Basic objectives2
Others
Basic objectives -Others
The results of this research are expected to provide fundamental data for elucidating the mechanisms behind compensation for swallowing and articulatory functions in post-operative patients with head and neck cancer. This could lead to the development of new rehabilitation techniques that differ from current practices, by uncovering the neural basis for functional recovery. It is considered a study of societal significance as it offers foundational insights necessary for developing such novel rehabilitation methods.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. No history of neurological disorders.
2. Ability to understand the explanation and provide confirmed consent.
3. Physique that allows for the wearing of headgear.
Key exclusion 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Suehiro |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology, Head & Neck Surgery
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3346
a_suehiro@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suehiro |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology, Head & Neck Surgery
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3346
Homepage URL
a_suehiro@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kodama foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto, Japan
Tel
075-751-4748
ctsodan@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective time-series analysis examining changes in brain activity related to swallowing and articulation in patients who have undergone surgery for head and neck cancer. Initially, swallowing movements are evaluated using a videofluoroscopic swallowing study (VFSS). Subsequently, brain activity during swallowing, imagining swallowing, and during articulatory movements is measured with an EEG device (multi-channel EEG system EEGoSport from ANT-Neuro).
Management information
Registered date
| 2024 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061542
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