Targeted Brain Rehabilitation for Phantom Limb Pain

Overseen By Joshua Steinke, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: OrthoCarolina Research Institute, Inc.

Disqualifiers: Uncontrolled mental illness, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Targeted Brain Rehabilitation to determine its effectiveness in preventing or reducing Phantom Limb Pain in individuals who have undergone a major amputation. The researchers divide participants into two groups: one receives the new treatment, while the other serves as a comparison group. Individuals who have had a major amputation with Dr. Gaston and Dr. Loeffler in the past 12-24 months or are scheduled for one soon may be suitable candidates, particularly if they are willing to use virtual reality daily after surgery. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in pain management following amputation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Targeted Brain Rehabilitation is safe for preventing or reducing Phantom Limb Pain?

Research has shown that Targeted Brain Rehabilitation (TBR) can help people with phantom limb pain. In earlier studies, about 60% of participants reported that the treatment reduced and controlled their pain. This indicates that many find TBR helpful and manageable. However, since everyone is different, results can vary. Discuss any safety concerns with a healthcare professional. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for phantom limb pain, which often involve medications like opioids or antidepressants to manage symptoms, Targeted Brain Rehabilitation aims to retrain the brain itself. This innovative approach directly targets the neural pathways involved in the perception of phantom limb sensations, potentially providing relief without the need for drugs. Researchers are excited because it could offer a non-invasive, drug-free option that addresses the root cause of the pain rather than just masking it.

What evidence suggests that Targeted Brain Rehabilitation is effective for Phantom Limb Pain?

Research has shown that Targeted Brain Rehabilitation (TBR), which participants in this trial may receive, can help reduce phantom limb pain (PLP). In one study, 60% of participants found TBR improved the sensation of their missing limb and reduced pain. Another study demonstrated that TBR significantly changed brain activity, which helped lower pain and fatigue. Overall, patients have reported up to a 90% reduction in pain after several TBR treatments. These findings suggest that TBR might be a promising option for managing PLP. ^{1 4 6 7 8}

Who Is on the Research Team?

Glenn Gaston, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for English-speaking patients aged 13 or older who are undergoing major amputation with Dr. Gaston and Dr. Loeffler, willing to use VR daily in the hospital post-amputation. It excludes those under 12, without guardian consent if under 18, with past extensive TBR use, uncontrolled mental illness, active neurological diseases or cognitive impairments.

Inclusion Criteria

Ability to read and comprehend English

I am willing to use virtual reality daily after my major amputation surgery.

I am 13 or older and will have a major amputation with Dr. Gaston or Dr. Loeffler within the next 12-24 months.

Exclusion Criteria

I have used a targeted muscle reinnervation (TMR) procedure for a previous amputation.

I do not have an uncontrolled mental illness.

I am over 12 and if between 13-17, I have a guardian to consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Participants receive prophylactic Targeted Brain Rehabilitation (TBR) using VR therapy immediately post-amputation to prevent or reduce Phantom Limb Pain (PLP)

12-24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, usability, and quality of life

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Brain Rehabilitation

Trial Overview The study tests Targeted Brain Rehabilitation (TBR) as a preventive treatment for Phantom Limb Pain (PLP). Participants will receive TBR via virtual reality (VR) during their inpatient stay following major limb amputation to see if it reduces PLP incidence or severity.

How Is the Trial Designed?

Group I: Control Group Active Control 1 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.

Group II: Treatment Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S036350232500468X

Targeted Brain Rehabilitation: Development, Feasibility ... Participants identified the guided motor execution phase as most helpful for phantom limb position (60%), control (70%), and pain reduction (60 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10205977/

Phantom limb therapy improves cortical efficiency of the ... The results demonstrated that phantom limb therapy produced significant changes of cortical activity, reduced fatigue, fluctuation in phantom ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06483035

Treatment of Phantom Limb Pain by Intensive Visual ... Pilot studies have shown promising results on pain reduction in people with phantom limb pain when using IVS-T. However, there is a lack of RCT studies on this ...

4. withpower.com withpower.com/trial/phase-phantom-limb-5-2025-9148e

Targeted Brain Rehabilitation for Phantom Limb Pain This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP) ...

5. wjgnet.com wjgnet.com/2218-5836/full/v16/i6/107422.htm

Innovative exploration of phantom limb pain treatment ... After five treatments, scores from three scales indicated a significant reduction in pain ratings by 55%, 60% and 90%. The execution of phantom ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12331023/

Treatment of Phantom and Residual Limb Pain in Amputees ... Our results indicate that TMR can effectively treat neuropathic pain in amputees, as evidenced by reductions in VAS scores of overall pain, PLP, ...

7. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-021-02441-z

Effects of phantom exercises on pain, mobility, and quality of ... The objective of the current study is to evaluate the effects of phantom exercises on phantom limb pain, mobility status, and quality of life in lower limb ...

8. trial.medpath.com trial.medpath.com/clinical-trial/6e122403803b7279/nct06956508-prophylactic-brain-rehab-phantom-limb-pain

Prophylactic TBR on Phantom Limb Pain | MedPath This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP) ...