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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT02487966
Eligibility Criteria:
Inclusion Criteria:
1. Able to provide informed consent to participate in the study.
2. Subject is older than 18 years.
3. Unilateral lower limb amputation.
4. Traumatic amputation greater than 1 year ago.
5. Chronic PLP for at least 3 months previous to enrollment in the study, experienced regularly for at least once a week.
6. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
7. If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.
Exclusion Criteria:
1. Pregnancy or trying to become pregnant in the next 2 months.
2. History of alcohol or drug abuse within the past 6 months as self-reported.
3. Presence of the following contraindication to transcranial direct current stimulation and transcranial magnetic stimulation
* Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel)
* Implanted neck or head electronic medical devices (e.g., cochlear implants, vagus nerve stimulator)
4. History of chronic pain previous to the amputation.
5. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
6. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
7. Uncontrolled Epilepsy or prior seizures within the last 1 year.
8. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).\*
9. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
10. History of neurosurgery, as self-reported.
11. Mirror Therapy in the previous 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02487966
Study Brief:
Protocol Section:
NCT02487966