Target Muscle Re-innervation and Regenerative Peripheral Nerve Interfaces Alone and in Combination for the Treatment of Residual and Phantom Limb Pain in Cancer Patients Who Have Received an Amputation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06840262
Status
Recruiting
Apply to this trial

Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Questionnaire Administration — OTHER
    Ancillary studies
  • Regenerative Peripheral Nerve Interface Surgery — PROCEDURE
    Undergo regenerative peripheral nerve interface surgery
  • Targeted Muscle Reinnervation — PROCEDURE
    Undergo targeted muscle reinnervation

Study Details

This clinical trial evaluates two surgical techniques (targeted muscle re-innervation \[TMR\] and regenerative peripheral nerve interfaces \[RPNI\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.

Key Dates

Start date
Aug 10, 2020
Status verified
Sep 2025
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1 (targeted muscle reinnervation)
    Patients undergo TMR procedure.
  • Active Comparator: Arm 2 (regenerative peripheral nerve interface)
    Patients undergo RPNI procedure.
  • Experimental: Arm 3 (TMI + RPNI)
    Patients undergo TMR in combination with RPNI.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Margaret S. Roubaud
[email protected]
713-794-1247
Margaret S. Roubaud (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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