Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT00013832
Eligibility Criteria:
* INCLUSION CRITERIA:
Eligible healthy volunteers must:
1. be at least 21 years of age;
2. have no speech, swallowing, or respiratory problems;
3. be in good general health;
4. not be on medications that would adversely affect swallowing ability.
Eligible dysphagic patients must:
1. be at least 21 years of age;
2. have a neurologic disorder (e.g., CVA, PD, PSD, CBD, MS, Gaucher, leukodystrophy, cerebral palsy), musculoskeletal disease (e.g., polymyositis), or head and neck cancer that has caused impairments in tongue function and swallowing;
3. present with oral or oropharyngeal dysphagia without aspiration based on results of the standard modified barium swallow study.
4. have sufficient auditory comprehension and cognitive skills to follow test instructions and understand the nature of the study.
EXCLUSION CRITERIA:
For healthy volunteers:
1. History of swallowing problems or other conditions that adversely affect swallowing function, tongue motility and control, hearing, language, and cognition.
2. On medication (e.g., anticholinergics, antidepressants) that adversely affects swallowing function, tongue movement, comprehension, or cognition.
3. Oral dryness that interferes with swallowing.
4. Unsatisfactory performance status, as judged by the examining speech-language pathologist, that indicates poor compliance for the planned tasks (e.g., undiagnosed oral motor deficits).
For dysphagic patients:
1. Aspiration, as identified via the modified barium swallow study.
2. Pregnancy, as determined via a urine pregnancy test prior to the MBS test.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00013832
Study Brief:
Protocol Section:
NCT00013832