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Neurostimulation for Chronic Upper Limb Pain After Brachial Plexus Injury

This study is looking at how high-frequency spinal cord stimulation (HF10 SCS) affects chronic pain in the upper arm after a brachial plexus injury (damage to the network of nerves that sends signals from your spinal cord to your shoulder, arm, and hand). You might be able to join if you are over 18, have had this type of neuropathic pain (nerve pain) for at least three months, and are already planning to receive HF10 SCS for your pain. The researchers want to see if this treatment helps reduce your pain intensity and improve your overall pain experience over time, with measurements taken regularly for up to three years. The study is currently observing participants, but its exact status is unclear.

Study design
This is an observational study that will follow about 20 adults who are receiving high-frequency spinal cord stimulation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 36 months (3 years) after starting treatment, with pain levels measured at several points during this time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04733599

Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~20 participants
Updated 2026-03-02 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in neuropathic pain
Measured over Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
+4 more outcomes measured

Conditions

Brachial Plexus Injury

Explore related trials

Brachial Plexus Injury

Where it's being run

2 sites across 2 states
Florida1
Minnesota1

Study leadership

  • Christy Hunt, DO · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Stephanie McNew
[email protected]
(904)953-0580
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change in neuropathic painBaseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using the patient reported Neuropathic Pain Symptom Inventory (NPSI) which uses a scale of 0 = "have not felt such pain" and 10 = "feel it the worst" for a total score with a higher score indicates greater pain.

  • Change in multidimensional pain inventoryBaseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using the West Haven-Yale Multidimensional pain inventory self-reported questionnaire to assess the impact of pain on daily living

  • Change in Douleur Neuropathique 4 (DN4) Questionnairebaseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Change in DN4 questionnaire to estimate the probability of neuropathic pain with seven questions asking patients about quality of pain and three questions for physical examination of pain. Questions are yes = 1 or no = 0 to obtain a patient's total score out of 10, higher scores indicate more probability of pain.

  • Change in pain intensityBaseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using the PROMIS-CAT pain intensity scale

  • Change in pain interferenceBaseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using the PROMIS-CAT pain interference scale