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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05103202
Eligibility Criteria:
Inclusion Criteria
Aim 1:
1. Patient provides responses to an internet based survey which includes consent to participate
2. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study
3. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators
4. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more
Aim 2:
1. Patient provides responses to an internet based survey which includes consent to participate
2. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study
3. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators
4. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more
5. If receiving injections at 12-weeks or more, notes must have previously indicated that patient needs an injection interval of 10-weeks or less
6. If receiving injections at 12-weeks or more, the reason must be that the insurance carrier covering that patient's medical costs refused to allow a 10-week or less injection frequency
Exclusion Criteria:
For both Aims 1 and 2:
1. Patient is unwilling to consent to study procedures (refuses to fill out surveys)
2. Patient has variable injection frequencies such that the two most recent injections do not both meet criteria of being 10-weeks or less in frequency or 12-weeks or more in frequency
3. Patient has a diagnosis of and is being treated for a condition for which a HRQoL scale does not exist
4. Patient has insufficient chart documentation to characterize demographics, diagnosis, toxin selected, dose used, and injection frequency employed
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05103202
Study Brief:
Protocol Section:
NCT05103202