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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02569918
Eligibility Criteria:
Inclusion Criteria:
* Amputation or peripheral nerve damage of an upper limb.
* Injury should be in the chronic, stable phase, such that any traumatic injuries or surgical wounds have healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiment.
* Other treatments for PLP tried with poor results.
* Patient accepts the study protocol as explained by the physician.
* The subject experienced intractable PLP (i.e. pain in the denervated or missing extremity) of more than 6 on numerical rating scale (NRS) or visual analog scale (VAS) (0-10 scale). The frequency of PLP episodes presents more than once a week.
* Amputee subjects without PLP are eligible for part of the study that targets the sensory feedback induction within advanced bidirectional prosthesis control.
Exclusion Criteria:
* Cognitive impairment
* Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I.
* Pregnancy
* History of or active substance abuse disorder
* Acquired brain injury with residual impairment
* Intellectual Disability (IQ \< 70)
* Prior neurological or musculoskeletal disease
* Current or prior dermatological conditions
* Excessive sensitivity to electrical stimulation with surface electrodes. People afraid of electrical stimulation or pain.
* People with other diseases which may affect the function of the nervous system. (Diabetes, HIV, Renal Failure)
* Patients implanted with pacemakers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02569918
Study Brief:
Protocol Section:
NCT02569918