By David Robinson
Oct. 26, 2018 | People with frequent and recurring pain from an amputated leg are being enrolled in a University of Arkansas for Medical Sciences (UAMS) research study of a device designed to reduce amputation pain.
Led at UAMS by Erika Petersen, M.D., a neurosurgeon and researcher, the study is part of a clinical trial being conducted at sites across the United States.
The study is testing the safety and effectiveness of an implanted device, Altius® High Frequency Nerve Block, that is designed to block nerve signals and reduce pain in an amputated limb. The investigational device sends a high-frequency electrical signal to targeted nerves to block the nerve transmission. It was developed by Neuros Medical Inc., in Cleveland, Ohio.
Called the QUEST study (High-FreQUEncy Nerve Block for PoST-Amputation Pain, ClinicalTrials.gov Identifier: NCT02221934), it is a randomized, controlled clinical study of up to 180 patients, at up to 25 clinical study sites in the U.S.
Study participants will undergo surgery to be implanted with the device. It includes a cuff electrode, which is coiled around the nerve, and a pulse generator, which is similar to a pacemaker. Together they deliver an electrical signal to the nerve when activated. Once implanted, study participants can activate a 30-minute treatment session on demand, as needed for their pain. Participants will be followed for a year and seen in clinic once a month. They will also receive modest compensation for their time and travel.
Eligibility requirements for participating in the study include:
- Having one amputated leg
- Frequent and recurring amputation pain
- 21 years of age or older
Those interested in learning if they are eligible may contact the UAMS Translational Research Institute study coordinator, 501-398-8622.
An earlier pilot study involving 10 participants demonstrated that the implant device may be safe and effective for post-amputation pain. (Soin A., Syed Shah N., Fang Z-P. 2015. High-Frequency Electrical Nerve Block for Postamputation Pain: A Pilot Study. Neuromodulation 2015; 18:197-206). DCO# 18-0030 / LB-0042 Rev. A / Effective May 23, 2018 Page 4 of 11.
The project described is supported by the Translational Research Institute (TRI), grant 1U54TR001629-01A1 through the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.