- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05876247
Articulatory Adaptation Following Oral Cancer Treatment (SPOKE)
Speech Flexibility in Adulthood Following Oral Cancer Treatment: Acoustic and Kinematic Explorations
The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies.
Participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Thomas Tienkamp, MA
- Phone Number: +31 50 36 37051
- Email: t.b.tienkamp@umcg.nl
Study Contact Backup
- Name: Max Witjes, PhD
- Phone Number: +31 (0)50 361 3841
- Email: m.j.h.witjes@umcg.nl
Study Locations
-
-
-
Groningen, Netherlands, 9713 GZ
- Recruiting
- University Medical Centre Groningen
-
Contact:
- Thomas Tienkamp, MA
- Phone Number: +31 50 36 37051
- Email: t.b.tienkamp@umcg.nl
-
Groningen, Netherlands, 9712 EK
- Recruiting
- Faculty of Arts, University of Groningen
-
Contact:
- Thomas Tienkamp, MA
- Phone Number: +31 50 36 37051
- Email: t.b.tienkamp@rug.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed with T1 or T2 tumor in the oral cavity
- At least 18 years old and able to provide informed consent
- Native speaker of Dutch
- Has nog been treated for oral cancer before
Exclusion Criteria:
1a. Recurrence of disease (for patients)
1b. Treated for oral cancer (for healthy controls) 2. Speech problems (e.g., stuttering) 3. Problems with sight or hearing that impede reading or understanding instructions. When glasses or a hearing aid resolve these problems, then participants are not excluded.
4. Neurological or psychological disorders (e.g., stroke) 5. Non-removable metal in, on or around the head (piercings, braces, pacemaker, electrodes) 6. Self-reported signs of depression
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Individuals treated for oral cancer
Dutch native speakers (18+) who will undergo surgical treatment for a T1 or T2 tumour on the tongue.
|
Motion tracking sensors will track articulatory movements of the tongue, jaw and lips
|
|
Control speakers
Dutch native speakers (18+) without self-reported speech problems.
|
Motion tracking sensors will track articulatory movements of the tongue, jaw and lips
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Articulatory gestures
Time Frame: 2022-2025
|
Articulatory movements in three dimensions of the tongue, lips and jaw as measured by the NDI Vox Electromagnetic Articulograph.
Measures include: articulator speed (mm/s), total displacement (mm), coordinates (x,y,z) during specific gestures.
|
2022-2025
|
|
Acoustic outcomes
Time Frame: 2022-2025
|
Speech acoustics will be measured in Praat and include the first and second formants of vowels (in Hz), global movement size in terms of acoustic working space (Hz-squared), and the centre of gravity of sibilants (in Hz)
|
2022-2025
|
Collaborators and Investigators
Investigators
- Principal Investigator: Max Witjes, PhD, University of Groningen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Head and Neck Neoplasms
- Stomatognathic Diseases
- Mouth Diseases
- Language Disorders
- Communication Disorders
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Mouth Neoplasms
- Speech Disorders
Other Study ID Numbers
- METc 2021/711
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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