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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Targeted Brain Rehabilitation for Phantom Limb Pain?

Research shows that visuomotor training, which involves matching movements of a phantom limb with a virtual hand, can reduce phantom limb pain by restoring activity in the brain's motor area. This suggests that treatments like Targeted Brain Rehabilitation, which may involve similar principles, could be effective in managing phantom limb pain. ^{1 2 3 4 5}

How does the treatment Targeted Brain Rehabilitation differ from other treatments for phantom limb pain?

Targeted Brain Rehabilitation is unique because it focuses on retraining the brain to reduce phantom limb pain by addressing changes in brain activity and organization, unlike other treatments that may not directly target these neural mechanisms. This approach is similar to sensory discrimination training and visuomotor training, which also aim to alter brain activity and improve sensory perception, but it may offer a more comprehensive method by integrating various brain rehabilitation techniques. ^{1 2 3 4 6}

What is the purpose of this trial?

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

Research Team

Glenn Gaston, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Illusory movements of the paralyzed limb restore motor cortex activity. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Recent advances in understanding and managing phantom limb pain. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of sensory discrimination training on cortical reorganisation and phantom limb pain. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Neuromodulation Techniques in Phantom Limb Pain: A Systematic Review and Meta-analysis. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

[Cortical reorganization and pain. Empirical findings and therapeutic implication using the example of phantom pain]. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Imaginative resonance training (IRT) achieves elimination of amputees' phantom pain (PLP) coupled with a spontaneous in-depth proprioception of a restored limb as a marker for permanence and supported by pre-post functional magnetic resonance imaging (fMRI). [2019]