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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT03318250
Eligibility Criteria:
Inclusion Criteria:
1. Subject is at least 18 years old at the time of informed consent
2. Subject is willing and able to provide a signed and dated informed consent
3. Subject is capable of independently comprehending and consenting to the requirements of the study
4. Subject is willing and able to comply with all study procedures, study visits, and be available for the duration of the study
5. Subject has been diagnosed with Neuropathic Pain with VAS pain scores ≥ 6 for at least 6 consecutive months
6. Pain distribution localized predominantly to 1 or 2 body dermatomes
7. Subject is on a stable dose (no new, discontinued or changes) of all prescribed pain medications for at least 4 weeks prior to screening and willing to maintain or only decrease the dose of all prescribed pain medications through Trial Assessment 2.
8. Subject has tried appropriate conventional medical management for their pain
Exclusion Criteria:
1. Subject has an active implanted device, whether turned on or off
2. Subject displays current signs of a systemic infection
3. Subject is pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
4. Subject has untreated major psychiatric comorbidity
5. Subject has serious drug-related behavioural issues (eg, alcohol dependency, illegal substance abuse)
6. Using greater than 120mg morphine equivalents of opioids daily
7. Structural abnormalities of the spine that may prevent electrode implantation
8. Co-existing disorder of the nervous system that may affect study measurements e.g polyneuropathy
9. Subjects has a requirement for planned MRI scanning in the future
10. Subject is diagnosed with Raynaud disease
11. Subject is diagnosed with Fibromyalgia
12. Subject has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
13. Subject has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
14. Subject is participating or planning to participate in another clinical trial
15. Subject has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03318250
Study Brief:
Protocol Section:
NCT03318250