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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT06702904
Eligibility Criteria:
Inclusion Criteria:
* Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
* Age between 18 and 65 years.
* Duration since amputation is at least 6 months.
* Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
* Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
* Signed consent to participate in the study.
Exclusion Criteria:
* Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
* Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
* Presence of severe orthopedic deformity in the limb above the level of amputation.
* History of cancer.
* History of epilepsy.
* Complicated traumatic brain injury (TBI) or a history of stroke.
* Inability to undergo electrostimulation due to other somatic pathology.
* Purulent-septic pathology.
* Drug addiction (including a history of).
* Congenital anomaly of upper limb development.
* Anomalies in the development of the central and peripheral nervous systems.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06702904
Study Brief:
Protocol Section:
NCT06702904