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

February 26, 2026 updated by: Christine (Christy) L. Hunt, Mayo Clinic

High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This single-site prospective observational cohort study will include all adults (> 18 years old) with brachial plexus avulsion injury who are candidates for high frequency (HF10) spinal cord stimulation (SCS). We plan to prospectively observe patients who undergo implantation of HF10 SCS for the indication of chronic neuropathic pain of the upper limb following brachial plexus avulsion injury.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in neuropathic pain
Time Frame: Baseline, 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.
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
Measured using the West Haven-Yale Multidimensional pain inventory self-reported questionnaire to assess the impact of pain on daily living
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 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.
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
Measured using the PROMIS-CAT pain intensity scale
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
Measured using the PROMIS-CAT pain interference scale
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using the self-reported DASH 30-item questionnaire to assess the ability to perform activities. Total score on a scale of 0 indicating no disability to 100 indicating most serve disability
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Assessment of the effectiveness of high frequency spinal cord stimulation in the above population in the improvement of quality of life as measured by validated patient-completed questionnaires.
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using the EQ-5D.
baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in mood
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using the Center for Epidemiologic Depression Studies - Depression Scale. A 20-item self-reported questionnaire using a scale of 0 (rarely or none of the time) and 3 (most or all of the time) for a total score with high scores indicating the presence of more
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain experience
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in self-reported 13-item Pain Catastrophizing scale of 0 (not at all) and 4 (all the time) for a total score with higher scores indicating higher levels of pain anxiety
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain anxiety
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using the self-reported Pain Anxiety Symptom Scale Short Form 20 to rate frequency of symptoms on a scale of 0 (never) to 5 (always) for a total score with higher score indicating high levels of pain-related anxiety
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Assessment of the effect of high frequency spinal cord stimulation in the above population on sensory function in the affected limb.
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using Quantitative Sensory Testing
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christy Hunt, DO, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-000910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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