Prophylactic TBR on Phantom Limb Pain

Conditions

• Phantom Limb Pain After Amputation

Eligibility Criteria

Sex

ALL

Age

13 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Targeted Brain Rehabilitation — OTHER
  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 Details

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

Key Dates

Start date

Feb 5, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control Group
  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.
• Active Comparator: Treatment Group
  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.

Primary Outcome Measure

Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Through study completion, an average of 1 year ]

Locations (1)

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