Phantom Limb Pain After AmputationNCT06956508
Prophylactic TBR on Phantom Limb Pain
A study testing Targeted Brain Rehabilitation in people with Phantom Limb Pain After Amputation, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Phantom Limb Pain After Amputation
- What is being tested?
- Targeted Brain Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
About this study
Official title: Assessing the Impact of Prophylactic Targeted Brain Rehabilitation (TBR) on Phantom Limb Pain in the Perioperative Period Following Major Amputation, A Prospective Study
This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP).
Read the 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 of major limb amputees in the United States projected to reach 3 million by 2050 and approximately 185,000 new cases annually, there is a pressing need for effective interventions to prevent and manage PLP.
Current pharmacologic treatments offer limited relief and can lead to adverse outcomes, particularly with long-term opioid use. Non-pharmacologic alternatives, such as mirror therapy, lack strong evidence supporting their efficacy and, to our knowledge, have not been evaluated in the perioperative period.
Virtual reality (VR) has emerged as a promising tool for mitigating various aspects of the phantom limb experience in major limb amputees. Previous research has shown that VR treatments can significantly reduce PLP, with many studies reporting a drop in numeric pain scores after VR use, and can be cost-effective. However, current literature on VR therapy for PLP has never evaluated its use in the immediate post operative period.
Initiating VR therapy immediately post-amputation may help in preventing maladaptive cortical reorganization, which is believed to be a key factor in the development of PLP. Following amputation, the sensory-motor cortex undergoes rapid rewiring as the brain attempts to compensate for the loss of sensory input from the amputated limb. This reorganization can lead to the formation of aberrant neural connections, contributing to the perception of phantom limb sensations and pain. By providing a virtual representation of the missing limb and facilitating its movement, VR therapy may be able to help maintain the integrity of the sensory-motor cortex, potentially preventing or reducing the development of PLP.
Our research team hypothesizes that prophylactic use of Targeted Brain Rehabilitation (TBR), a VR-based therapy system, in the perioperative period following major amputation can prevent or reduce the development of PLP and decrease the usage of opioids in this population. Furthermore, introducing VR therapy in the immediate post-operative period could help mitigate the psychological distress associated with amputation. By addressing both the physical and psychological aspects of amputation from the outset, prophylactic VR therapy has the potential to significantly improve the quality of life for amputees and reduce the long-term burden of PLP. Establishing the efficacy of prophylactic TBR in the perioperative period could revolutionize the standard of care for amputees, potentially reducing the incidence and severity of PLP and its associated psychological and quality of life impacts. This study will lay the groundwork for future multi-center, randomized controlled trials to validate the effectiveness of prophylactic TBR and establish it as a potential standard of care for amputees.
- Conditions
- Phantom Limb Pain After Amputation
- Being tested
- Targeted Brain Rehabilitation
- Keywords
- Phantom Limb Pain, Targeted Brain Rehabilitation, VR, Virtual Reality
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Brain RehabilitationOther
Patients will be given a virtual reality headset that is pre-loaded with the targeted brain rehabilitation (TBR) software at the time of their major amputation.
The Virtual Reality (VR) environment will consist of a high-fidelity virtual representation of the participant's phantom limb. Participants will use a mounted head display (MHD) to interact with a virtual avatar, with the phantom limb represented as a realistic 3D limb model matching the remaining anatomy and skin tone. The VR system will be set up either in the clinic or at the participant's home, depending on individual circumstances and preferences.
The VR protocol will be standardized and include exercises designed to mimic typical occupational therapy session.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will be any patients, 13 years old or older, who underwent major amputation with Dr. Gaston and Dr. Loeffler in 12-24 months before this trial started. |
| Treatment Group | Active comparator | The treatment group will be any patients, 13 years of age or older, who undergo major amputation with Dr. Gaston and Dr. Loeffler for 12-24 months after the start of the study. Receives: Other: Targeted Brain Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form McGill Pain Questionnaire (SF-MPQ)
Assesses quality/intensity of their pain experience using descriptive words. Consists of 15 descriptors rated on an intensity scale. Includes visual analog scale (VAS). Administered to both groups. One composite score.
Measured: Through study completion, an average of 1 year
Secondary outcomes (10)
Numeric Pain Rating Scale (NPRS)
Self-report pain on a scale of 0-10, where 0 means no pain and 10 means the worst pain imaginable
Measured: Through study completion, an average of 1 year
Brief Pain Inventory (BPI) - Short Form
9-item questionnaire to assess pain severity and interference (two composite scores)
Measured: Through study completion, an average of 1 year
Phantom Limb Experience Survey
Assesses presence, onset, location, character, intensity, triggers, and treatment of phantom limb sensations and phantom limb pain. Includes questions on phantom limb posture, movement, size changes, and telescoping.
Measured: Through study completion, an average of 1 year
Phantom Limb Assessment
Assesses frequency, duration, and intensity of phantom limb pain compared to previous session. Assesses phantom limb posturing and control of phantom limb. Assesses duration of treatment effects in intervention group.
Measured: Through study completion, an average of 1 year
Simulator Sickness Questionnaire
Assesses symptoms of simulator sickness including nausea, oculomotor problems, and disorientation. Only administered to intervention group.
Measured: Through study completion, an average of 1 year
System Usability Scale (SUS)
Assesses subjective usability and satisfaction with the VR system. Scores range from 0 to 100, with higher scores indicating better usability.
Measured: Through study completion, an average of 1 year
Overall VR experience and feedback survey
Supplemental questions to SUS
Measured: Through study completion, an average of 1 year
EuroQol five-dimensional health questionnaire (EQ-5D-5L)
Assesses generic health status, quality of life, anxiety/depression
Measured: Through study completion, an average of 1 year
Patient Health Questionnaire-9 (PHQ-9)
Objectifies and assesses degree of depression severity via questionnaire. Score ranges from 0 to 27, with higher scores indicating more severe depression.
Measured: Through study completion, an average of 1 year
Daily Pain Log - Additional Questions
Assesses frequency and duration of phantom limb pain each day.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start5 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb Pain After AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All Control Group patients will be retrospective subjects. Treatment Groups will be a single intervention enrolled prospectively.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Gaston, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956508
- Sponsor's protocol ID
- 9219 (HAND141)
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rutledge T, Velez D, Depp C, McQuaid JR, Wong G, Jones RCW, Atkinson JH, Giap B, Quan A, Giap H. A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. Pain Med. 2019 Oct 1;20(10):2051-2059. doi: 10.1093/pm/pnz121.
PubMed 31165893Rothgangel, A. S., Braun, S., Schulz, R. J., Kraemer, M., de Witte, L., Beurskens, A., & Smeets, R. J. (2018). The PACT trial: patient centered telerehabilitation program for post-acute coronary artery disease patients. A prospective, multicenter, randomized controlled trial. Journal of Clinical Medicine, 7(10), 355.
Rothgangel A, Braun S, Winkens B, Beurskens A, Smeets R. Traditional and augmented reality mirror therapy for patients with chronic phantom limb pain (PACT study): results of a three-group, multicentre single-blind randomized controlled trial. Clin Rehabil. 2018 Dec;32(12):1591-1608. doi: 10.1177/0269215518785948. Epub 2018 Jul 16.
PubMed 30012007MacIver K, Lloyd DM, Kelly S, Roberts N, Nurmikko T. Phantom limb pain, cortical reorganization and the therapeutic effect of mental imagery. Brain. 2008 Aug;131(Pt 8):2181-91. doi: 10.1093/brain/awn124. Epub 2008 Jun 20.
PubMed 18567624Wand BM, Parkitny L, O'Connell NE, Luomajoki H, McAuley JH, Thacker M, Moseley GL. Cortical changes in chronic low back pain: current state of the art and implications for clinical practice. Man Ther. 2011 Feb;16(1):15-20. doi: 10.1016/j.math.2010.06.008. Epub 2010 Jul 23.
PubMed 20655796Ambron E, Miller A, Kuchenbecker KJ, Buxbaum LJ, Coslett HB. Immersive Low-Cost Virtual Reality Treatment for Phantom Limb Pain: Evidence from Two Cases. Front Neurol. 2018 Feb 19;9:67. doi: 10.3389/fneur.2018.00067. eCollection 2018.
PubMed 29515513Vassantachart AY, Yeo E, Chau B. Virtual and Augmented Reality-based Treatments for Phantom Limb Pain: A Systematic Review. Innov Clin Neurosci. 2022 Oct-Dec;19(10-12):48-57.
PubMed 36591552Barbin J, Seetha V, Casillas JM, Paysant J, Perennou D. The effects of mirror therapy on pain and motor control of phantom limb in amputees: A systematic review. Ann Phys Rehabil Med. 2016 Sep;59(4):270-5. doi: 10.1016/j.rehab.2016.04.001. Epub 2016 May 30.
PubMed 27256539Alviar MJ, Hale T, Dungca M. Pharmacologic interventions for treating phantom limb pain. Cochrane Database Syst Rev. 2016 Oct 14;10(10):CD006380. doi: 10.1002/14651858.CD006380.pub3.
PubMed 27737513Von Korff MR. Long-term use of opioids for complex chronic pain. Best Pract Res Clin Rheumatol. 2013 Oct;27(5):663-72. doi: 10.1016/j.berh.2013.09.011. Epub 2013 Oct 5.
PubMed 24315147Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
PubMed 18295618Padovani MT, Martins MR, Venancio A, Forni JE. Anxiety, depression and quality of life in individuals with phantom limb pain. Acta Ortop Bras. 2015 Mar-Apr;23(2):107-10. doi: 10.1590/1413-78522015230200990.
PubMed 27069411van der Schans CP, Geertzen JH, Schoppen T, Dijkstra PU. Phantom pain and health-related quality of life in lower limb amputees. J Pain Symptom Manage. 2002 Oct;24(4):429-36. doi: 10.1016/s0885-3924(02)00511-0.
PubMed 12505212
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Prophylactic Targeted Brain Rehabilitation (TBR) on Phantom Limb Pain in the Perioperative Period Following Major Amputation, A Prospective Study
- ClinicalTrials.gov ID
- NCT06956508
- Acronym / sponsor ID
- 9219 (HAND141)
- Conditions
- Phantom Limb Pain After Amputation
- Keywords
- Phantom Limb Pain, Targeted Brain Rehabilitation, VR, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of major limb amputees in the United States projected to reach 3 million by 2050 and approximately 185,000 new cases annually, there is a pressing need for effective interventions to prevent and manage PLP.
Current pharmacologic treatments offer limited relief and can lead to adverse outcomes, particularly with long-term opioid use. Non-pharmacologic alternatives, such as mirror therapy, lack strong evidence supporting their efficacy and, to our knowledge, have not been evaluated in the perioperative period.
Virtual reality (VR) has emerged as a promising tool for mitigating various aspects of the phantom limb experience in major limb amputees. Previous research has shown that VR treatments can significantly reduce PLP, with many studies reporting a drop in numeric pain scores after VR use, and can be cost-effective. However, current literature on VR therapy for PLP has never evaluated its use in the immediate post operative period.
Initiating VR therapy immediately post-amputation may help in preventing maladaptive cortical reorganization, which is believed to be a key factor in the development of PLP. Following amputation, the sensory-motor cortex undergoes rapid rewiring as the brain attempts to compensate for the loss of sensory input from the amputated limb. This reorganization can lead to the formation of aberrant neural connections, contributing to the perception of phantom limb sensations and pain. By providing a virtual representation of the missing limb and facilitating its movement, VR therapy may be able to help maintain the integrity of the sensory-motor cortex, potentially preventing or reducing the development of PLP.
Our research team hypothesizes that prophylactic use of Targeted Brain Rehabilitation (TBR), a VR-based therapy system, in the perioperative period following major amputation can prevent or reduce the development of PLP and decrease the usage of opioids in this population. Furthermore, introducing VR therapy in the immediate post-operative period could help mitigate the psychological distress associated with amputation. By addressing both the physical and psychological aspects of amputation from the outset, prophylactic VR therapy has the potential to significantly improve the quality of life for amputees and reduce the long-term burden of PLP. Establishing the efficacy of prophylactic TBR in the perioperative period could revolutionize the standard of care for amputees, potentially reducing the incidence and severity of PLP and its associated psychological and quality of life impacts. This study will lay the groundwork for future multi-center, randomized controlled trials to validate the effectiveness of prophylactic TBR and establish it as a potential standard of care for amputees.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All Control Group patients will be retrospective subjects. Treatment Groups will be a single intervention enrolled prospectively.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will be any patients, 13 years old or older, who underwent major amputation with Dr. Gaston and Dr. Loeffler in 12-24 months before this trial started. |
| Treatment Group | Active comparator | Other: Targeted Brain RehabilitationThe treatment group will be any patients, 13 years of age or older, who undergo major amputation with Dr. Gaston and Dr. Loeffler for 12-24 months after the start of the study. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Brain RehabilitationPatients will be given a virtual reality headset that is pre-loaded with the targeted brain rehabilitation (TBR) software at the time of their major amputation. The Virtual Reality (VR) environment will consist of a high-fidelity virtual representation of the participant's phantom limb. Participants will use a mounted head display (MHD) to interact with a virtual avatar, with the phantom limb represented as a realistic 3D limb model matching the remaining anatomy and skin tone. The VR system will be set up either in the clinic or at the participant's home, depending on individual circumstances and preferences. The VR protocol will be standardized and include exercises designed to mimic typical occupational therapy session. | Other | Treatment Group |
Primary outcome
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Through study completion, an average of 1 year
Assesses quality/intensity of their pain experience using descriptive words. Consists of 15 descriptors rated on an intensity scale. Includes visual analog scale (VAS). Administered to both groups. One composite score.
10 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Through study completion, an average of 1 year
Brief Pain Inventory (BPI) - Short Form
Time frame: Through study completion, an average of 1 year
Phantom Limb Experience Survey
Time frame: Through study completion, an average of 1 year
Phantom Limb Assessment
Time frame: Through study completion, an average of 1 year
Simulator Sickness Questionnaire
Time frame: Through study completion, an average of 1 year
System Usability Scale (SUS)
Time frame: Through study completion, an average of 1 year
Overall VR experience and feedback survey
Time frame: Through study completion, an average of 1 year
EuroQol five-dimensional health questionnaire (EQ-5D-5L)
Time frame: Through study completion, an average of 1 year
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Through study completion, an average of 1 year
Daily Pain Log - Additional Questions
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 31165893Rutledge T, Velez D, Depp C, McQuaid JR, Wong G, Jones RCW, Atkinson JH, Giap B, Quan A, Giap H. A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. Pain Med. 2019 Oct 1;20(10):2051-2059. doi: 10.1093/pm/pnz121.
- BackgroundRothgangel, A. S., Braun, S., Schulz, R. J., Kraemer, M., de Witte, L., Beurskens, A., & Smeets, R. J. (2018). The PACT trial: patient centered telerehabilitation program for post-acute coronary artery disease patients. A prospective, multicenter, randomized controlled trial. Journal of Clinical Medicine, 7(10), 355.
- Background: PubMed 30012007Rothgangel A, Braun S, Winkens B, Beurskens A, Smeets R. Traditional and augmented reality mirror therapy for patients with chronic phantom limb pain (PACT study): results of a three-group, multicentre single-blind randomized controlled trial. Clin Rehabil. 2018 Dec;32(12):1591-1608. doi: 10.1177/0269215518785948. Epub 2018 Jul 16.
- Background: PubMed 18567624MacIver K, Lloyd DM, Kelly S, Roberts N, Nurmikko T. Phantom limb pain, cortical reorganization and the therapeutic effect of mental imagery. Brain. 2008 Aug;131(Pt 8):2181-91. doi: 10.1093/brain/awn124. Epub 2008 Jun 20.
- Background: PubMed 20655796Wand BM, Parkitny L, O'Connell NE, Luomajoki H, McAuley JH, Thacker M, Moseley GL. Cortical changes in chronic low back pain: current state of the art and implications for clinical practice. Man Ther. 2011 Feb;16(1):15-20. doi: 10.1016/j.math.2010.06.008. Epub 2010 Jul 23.
- Background: PubMed 29515513Ambron E, Miller A, Kuchenbecker KJ, Buxbaum LJ, Coslett HB. Immersive Low-Cost Virtual Reality Treatment for Phantom Limb Pain: Evidence from Two Cases. Front Neurol. 2018 Feb 19;9:67. doi: 10.3389/fneur.2018.00067. eCollection 2018.
- Background: PubMed 36591552Vassantachart AY, Yeo E, Chau B. Virtual and Augmented Reality-based Treatments for Phantom Limb Pain: A Systematic Review. Innov Clin Neurosci. 2022 Oct-Dec;19(10-12):48-57.
- Background: PubMed 27256539Barbin J, Seetha V, Casillas JM, Paysant J, Perennou D. The effects of mirror therapy on pain and motor control of phantom limb in amputees: A systematic review. Ann Phys Rehabil Med. 2016 Sep;59(4):270-5. doi: 10.1016/j.rehab.2016.04.001. Epub 2016 May 30.
- Background: PubMed 27737513Alviar MJ, Hale T, Dungca M. Pharmacologic interventions for treating phantom limb pain. Cochrane Database Syst Rev. 2016 Oct 14;10(10):CD006380. doi: 10.1002/14651858.CD006380.pub3.
- Background: PubMed 24315147Von Korff MR. Long-term use of opioids for complex chronic pain. Best Pract Res Clin Rheumatol. 2013 Oct;27(5):663-72. doi: 10.1016/j.berh.2013.09.011. Epub 2013 Oct 5.
- Background: PubMed 18295618Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
- Background: PubMed 27069411Padovani MT, Martins MR, Venancio A, Forni JE. Anxiety, depression and quality of life in individuals with phantom limb pain. Acta Ortop Bras. 2015 Mar-Apr;23(2):107-10. doi: 10.1590/1413-78522015230200990.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Gaston, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Brain Rehabilitation in people with Phantom Limb Pain After Amputation, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form McGill Pain Questionnaire (SF-MPQ) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956508, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.