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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00856518
Eligibility Criteria:
Inclusion Criteria:
* Multiple Sclerosis Participants
* Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist
* Over 85% of the patient populations that come from the study sites demonstrate relapsing-remitting MS with an average relapse frequency of once every 3 years
Parkinson's Disease Participants
* Hoehn \& Yahr, stage II and III as indicated by certified movement disorders neurologist
All Participants
* Between 35 and 80 years of age
* Non-smoking or no smoking within the previous five years
* No history of head and neck cancer, asthma or COPD, untreated hypertension
* Sufficient facial muscle strength so as to achieve and maintain adequate lip closure around a circular mouthpiece
* Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE; 1975No neurological (other than MS or PD) condition which adversely affects respiratory muscle or gas exchange system
* Reduced MEP's compared to published normative data for age and sex
* Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s for 65 and older) during voluntary cough production for age and sex (Bolser, personal communication; Smith-Hammond \& Goldstein, 2006)
* Participant report of symptoms related to swallow impairment
Exclusion Criteria:
* DBS
* COPD
* Asthma
* Smoking or smoking within preceding 5 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT00856518
Study Brief:
Protocol Section:
NCT00856518