Brachial Plexus InjuryNCT04733599
Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury
An observational study of Brachial Plexus Injury, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brachial Plexus Injury
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Stephanie McNew, (904)953-0580, McNew.Stephanie@mayo.edu
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Stephanie McNew, 904-953-0580, McNew.Stephanie@mayo.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Brachial Plexus Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropathic pain
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.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in multidimensional pain inventory
Measured using the West Haven-Yale Multidimensional pain inventory self-reported questionnaire to assess the impact of pain on daily living
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in Douleur Neuropathique 4 (DN4) Questionnaire
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.
Measured: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain intensity
Measured using the PROMIS-CAT pain intensity scale
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain interference
Measured using the PROMIS-CAT pain interference scale
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary outcomes (6)
Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score
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
Measured: 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.
Measured using the EQ-5D.
Measured: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in mood
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
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain experience
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
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain anxiety
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
Measured: 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.
Measured using Quantitative Sensory Testing
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Feb 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine (Christy) L. Hunt, Mayo Clinic
- Investigators
- Christy Hunt, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733599
- Sponsor's protocol ID
- 20-000910
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2021
- Last updated
- 2 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04733599
- Acronym / sponsor ID
- 20-000910
- Conditions
- Brachial Plexus Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
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
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
6 secondary outcomes
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
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
Change in mood
Time frame: 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 pain anxiety
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christy Hunt, DO principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Injury, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.