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 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT03350061
Eligibility Criteria:
Inclusion Criteria:
* Uni-lateral transfemoral amputation above the knee level
* Other treatments for phantom limb pain should have been tried with poor results
* The subject should experience phantom limb pain at a level of 6 or higher measured on on a visual analog scale (VAS) ranging from 0-10
* Phantom limb pain should be experienced at least once a week
* The subject should be in a chronic and stable phase, and the stump should have healed
* The subject should otherwise be healthy and able to carry out the experiment
* If pain medication is used it will be acceptable that the person continues to use the medication
Exclusion Criteria:
* Cognitive impairment
* Pregnancy
* Prior or current psychological diseases such as borderline, schizophrenia, depression or maniodepression
* Acquired brain injury with residual impairment
* Prior neurological or musculoskeletal diseases
* History of or active substance abuse disorder
* Excessive sensitivity to electrical stimulation with surface electrodes
* Persons with fear for electrical stimulation, pain cannot participate
* Persons that are hypersensitive to electrical stimulation and experience the stimulation as unpleasant cannot participate
* Since the protocol includes MRI scanning of the brain, persons that may feel claustrophobic cannot participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03350061
Study Brief:
Protocol Section:
NCT03350061