Recruiting

Neurostimulation

Sponsor:

Mayo Clinic

Code:

NCT04733599

Conditions

Brachial Plexus Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to see how much pain intensity is affected by high frequency spinal cord stimulation therapy in individuals with serious brachial plexus injury.

Conditions

Brachial Plexus Injury

Study ID

NCT04733599

Start date

Feb 1, 2021

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18 years old
  • Neuropathic pain of the upper limb ≥ 3 months following brachial plexus avulsion injury.
  • Patients must be planned to undergo implantation of high-frequency spinal cord stimulation for the treatment of chronic neuropathic pain due to brachial plexus avulsion injury.

Exclusion Criteria:

  • Pain that is non-neuropathic as defined by DN4 score <4.
  • Pregnant at the time of consideration for implant or planning to become pregnant during the study duration.
  • Active substance use disorder of any kind.
  • Active tobacco use.
  • Use of moderate or high dose opioid medication (oral morphine equivalents >100 mg daily).
  • Active, untreated major psychiatric disorder that might interfere with subject's ability to participate.
  • Involvement in active litigation related to injury.
  • Patient has not undergone conservative medical management for at least 3 months (including physical and/or occupational therapy and at least one trial of neuropathic pain medication).

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults with pain due to brachial plexus avulsion injury

Adult patients with history of brachial plexus avulsion injury referred for consideration of neuromodulation using high frequency neurostimulation will be considered.

Primary outcome measure

  • Change in neuropathic pain [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months ]
  • Change in multidimensional pain inventory [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months ]
  • Change in Douleur Neuropathique 4 (DN4) Questionnaire [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months ]
  • Change in pain intensity [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months ]
  • Change in pain interference [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Stephanie McNew

(904)953-0580McNew.Stephanie@mayo.edu

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Stephanie McNew

904-953-0580McNew.Stephanie@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-02.