Status:
NOT_YET_RECRUITING
Prophylactic TBR on Phantom Limb Pain
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Conditions:
Phantom Limb Pain After Amputation
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP).
Detailed Description
Phantom limb pain (PLP) affects 60-80% of amputees, including both upper and lower extremity amputees, leading to increased anxiety, depression, and reduced quality of life. With the total prevalence ...
Eligibility Criteria
Inclusion
- 13+ year old patients undergoing major amputation with Dr. Gaston and Dr. Loeffler in the 12-24 months after the start of this study.
- Ability to read and comprehend English.
- Willing to use VR daily while in the inpatient setting following major amputation.
Exclusion
- Patients under 12 years of age, and patients aged 13-17 without a legal guardian to give consent.
- Have used TBR extensively in the past for prior/unrelated amputation.
- Active uncontrolled mental illness
- Active neurological disease or cognitive impairment that would interfere with VR therapy or survey completion.
- Non-English speaking (surveys will only be provided in English)
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06956508
Start Date
August 15 2025
End Date
December 31 2028
Last Update
August 3 2025
Active Locations (1)
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1
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207