Recruiting

Target Muscle Re-Innervation & Regenerative Peripheral Nerve Interfaces

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06840262

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaire Administration

Regenerative Peripheral Nerve Interface Surgery

Targeted Muscle Reinnervation

Study Details

Brief summary:

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.

Conditions

Amputation

Study ID

NCT06840262

Start date

Aug 10, 2020

Status verified date

Oct, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons
  • Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue
  • Patients able to complete informed consent

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients unable to give consent
  • Patients receiving an amputation for non-oncologic purposes
  • Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect
  • Patients with multiple limb amputations
  • Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)

Study Design

Enrollment

57 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Questionnaire Administration

Ancillary studies

Regenerative Peripheral Nerve Interface Surgery

Undergo regenerative peripheral nerve interface surgery

Targeted Muscle Reinnervation

Undergo targeted muscle reinnervation

Primary outcome measure

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

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Margaret S. Roubaud

713-794-1247msroubaud@mdanderson.org

Principal Investigator:

Margaret S. Roubaud

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.