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 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT02221934
Eligibility Criteria:
Key Inclusion Criteria:
* Age ≥ 21 years old
* Unilateral amputated leg ≥ 12 months
* Chronic post amputation pain ≥ 6 months
* Pain episodes typically lasting ≥ 60 minutes
* Stable drug regimen ≥ 4 weeks
* No changes to medications or prosthesis for 3-month primary study period
Key Exclusion Criteria:
* Implanted with an active implantable medical device (i.e. pacemaker)
* Confounding source of pain that interferes with reporting of limb pain
* Uncontrolled diabetes
* Spasticity preventing full range of motion of involved side
* Extremely short stump; sits on end
* Untreated psychological condition (i.e. borderline personality)
* Condition requiring MRI studies or diathermy after device implant
* Life expectancy of less than 24 months
* Progressive neurological disease (i.e. multiple sclerosis)
* Subjects with active local or systemic infection or immunocompromised
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02221934
Study Brief:
Protocol Section:
NCT02221934