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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT01462461
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, 18 to 65 years of age, active duty military, beneficiary, or retiree.
* Written informed consent and written authorization for use or release of health and research study information.
* At least one upper-limb amputation (trans radial or trans humeral) at any time prior to enrollment.
* No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
* Normal neurological examination with the exception of limb amputation.
* Ability to follow study instructions and likely to complete all required visits.
* Experiencing PLP at least 3 times a week at an intensity of at least 3 out of 10 at the time of enrollment.
Exclusion Criteria:
* Presence of mild to severe traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening that is currently performed routinely on patients by the traumatic brain injury (TBI) program at Walter Reed National Military Medical Center (WRNMMC) and noted in the patient's medical record.
* Known uncontrolled systemic disease
* Participation (either concurrently or in the 30 days prior to enrollment) in another study for treatment of PLP
* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound study results, or interfere significantly with the subject's participation in the study.
* Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study
* Subjects with lack of effort as determined by the neurologist or psychiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) in order to exclude those with blatant exaggeration or malingering. Subjects who score lower than 42/50 on the TOMM-2 will not continue in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01462461
Study Brief:
Protocol Section:
NCT01462461