Post-Amputation PainNCT02221934
Electrical Nerve Block for Amputation Pain
A study testing Altius in people with Post-Amputation Pain and Phantom Limb Pain, run by Neuros Medical, Inc. at 22 sites in United States.
Trial summary
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain
- What is being tested?
- Altius
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 22 sitesUnited States
- Study dates
- 9 Oct 2014to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years old
- Unilateral amputated leg ≥ 12 months
- Chronic post amputation pain ≥ 6 months
- Pain episodes typically lasting ≥ 60 minutes
- Stable drug regimen ≥ 4 weeks
- No changes to medications or prosthesis for 3-month primary study period
Who cannot join
- Implanted with an active implantable medical device (i.e. pacemaker)
- Confounding source of pain that interferes with reporting of limb pain
- Uncontrolled diabetes
- Spasticity preventing full range of motion of involved side
- Extremely short stump; sits on end
- Untreated psychological condition (i.e. borderline personality)
Show all 10Show fewer
- Condition requiring MRI studies or diathermy after device implant
- Life expectancy of less than 24 months
- Progressive neurological disease (i.e. multiple sclerosis)
- Subjects with active local or systemic infection or immunocompromised
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Emory University / Grady Hospital
Atlanta, Georgia, 30303
Legacy Brain & Spine LLC
Atlanta, Georgia, 30339
University of Illinois Chicago
Chicago, Illinois, 60612
Cleveland Clinic Pain Management
Cleveland, Ohio, 44106
Baylor Scott and White Research Institute
Dallas, Texas, 75201
Meta Medical Research Institute
Dayton, Ohio, 45432
HCA Healthcare Research Institute / St. Luke's Presbyterian
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
University of Louisville
Louisville, Kentucky, 40202
Drug Studies America
Marietta, Georgia, 30060
Cardiovascular Surgery Clinic
Memphis, Tennessee, 38120
The Surgical Clinic
Nashville, Tennessee, 37203
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Advanced Surgical and Research Solutions
Oklahoma City, Oklahoma, 73134
Nona Medical Arts
Orlando, Florida, 32827
Mayo Clinic
Rochester, Minnesota, 55905
Arizona Pain Institute
Scottsdale, Arizona, 85258
University of Washington Medical Center
Seattle, Washington, 98195
Kettering Medical Center
Springboro, Ohio, 45066
Baylor Scott and White - Temple Memorial Vascular Surgery
Temple, Texas, 76508
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
Read the detailed description
The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
- Being tested
- Altius
- Keywords
- Pain, Chronic, Amputation, Phantom Pain, Stump Pain
- Medical subject headings
- Phantom Limb, Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AltiusDevice
Electrical signal
| Study group | Role | What they receive |
|---|---|---|
| Test Treatment | Experimental | Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius. Receives: Device: Altius |
| Active Sham Control Treatment | Active comparator | Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius. Receives: Device: Altius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
Demonstration of 50% reduction in a Numerical Rating Scale (NRS; 0-10 Scale; with 10 being the highest pain imaginable) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
Measured: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
Measured: From screening injection visit through 3 months post implant
Secondary outcomes (6)
Secondary Effectiveness: Pain Relief After 2 Hours
Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment
Measured: 12 months post implant
Secondary Effectiveness: Pain Medication Use
Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
Measured: 12 months post implant
Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL
Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.
Measured: 12 months post implant
Secondary Effectiveness: Health-related Quality of Life (HR-QOL)
EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.
Measured: 12 months post implant
Secondary Effectiveness: Patient Global Impression of Change (PGIC)
Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits
Measured: 12 months post implant
Secondary Safety
Incidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.
Measured: 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study start9 Oct 2014
- Primary completion31 Dec 2021
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-Amputation PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuros Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonardo Kapural, MD, PhD, Principal investigator, Center for Clinical Research, Winston-Salem NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221934
- Sponsor's protocol ID
- 003-0001
- Other IDs
- QUEST Trial
- Status last verified
- Oct 2024
- First submitted
- 15 Aug 2014
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.
PubMed 25655583Kapural L, Syed Shah N, Fang ZP, Mekhail N. Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). J Pain Res. 2022 Jun 3;15:1623-1631. doi: 10.2147/JPR.S353674. eCollection 2022.
PubMed 35685299Kapural L, Melton J, Kim B, Mehta P, Sigdel A, Bautista A, Petersen EA, Slavin KV, Eidt J, Wu J, Elshihabi S, Schwalb JM, Garrett HE Jr, Veizi E, Barolat G, Rajani RR, Rhee PC, Guirguis M, Mekhail N. Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain. J Pain Res. 2024 Jun 6;17:2001-2014. doi: 10.2147/JPR.S463727. eCollection 2024.
PubMed 38860215Kapural L, Kim B, Eidt J, Petersen EA, Schwalb JM, Slavin KV, Mekhail N. Long-Term Treatment of Chronic Postamputation Pain With Bioelectric Nerve Block: Twelve-Month Results of the Randomized, Double-Blinded, Cross-Over QUEST Study. Neuromodulation. 2024 Dec;27(8):1383-1392. doi: 10.1016/j.neurom.2024.08.010. Epub 2024 Sep 24.
PubMed 39320284Kapural L, Pullen J, Hargus NJ. High-frequency nerve block treatment for chronic post-amputation pain over 12 months: plain language summary of the QUEST trial. Pain Manag. 2026 Jul;16(7):685-702. doi: 10.1080/17581869.2026.2653162. Epub 2026 Apr 30.
PubMed 42057742
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
- ClinicalTrials.gov ID
- NCT02221934
- Acronym / sponsor ID
- 003-0001
- Keywords
- Pain, Chronic, Amputation, Phantom Pain, Stump Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Neuros Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2014 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Posted 11 Sep 2023
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 the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
Detailed description
The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Treatment | Experimental | Device: AltiusSelf-initiated high frequency bioelectric nerve block delivered to the nerve by Altius. |
| Active Sham Control Treatment | Active comparator | Device: AltiusSelf-initiated non-therapeutic electrical signal delivered to the nerve by Altius. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 21 years old
- Unilateral amputated leg ≥ 12 months
- Chronic post amputation pain ≥ 6 months
- Pain episodes typically lasting ≥ 60 minutes
- Stable drug regimen ≥ 4 weeks
Key exclusion criteria (10 listed)
- Implanted with an active implantable medical device (i.e. pacemaker)
- Confounding source of pain that interferes with reporting of limb pain
- Uncontrolled diabetes
- Spasticity preventing full range of motion of involved side
- Extremely short stump; sits on end
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AltiusElectrical signal | Device | Active Sham Control Treatment, Test Treatment |
Primary outcome
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
Time frame: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Demonstration of 50% reduction in a Numerical Rating Scale (NRS; 0-10 Scale; with 10 being the highest pain imaginable) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Time frame: From screening injection visit through 3 months post implant
Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
6 secondary outcomes
Secondary Effectiveness: Pain Relief After 2 Hours
Time frame: 12 months post implant
Secondary Effectiveness: Pain Medication Use
Time frame: 12 months post implant
Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL
Time frame: 12 months post implant
Secondary Effectiveness: Health-related Quality of Life (HR-QOL)
Time frame: 12 months post implant
Secondary Effectiveness: Patient Global Impression of Change (PGIC)
Time frame: 12 months post implant
Secondary Safety
Time frame: 12 months post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25655583Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.
- Background: PubMed 35685299Kapural L, Syed Shah N, Fang ZP, Mekhail N. Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). J Pain Res. 2022 Jun 3;15:1623-1631. doi: 10.2147/JPR.S353674. eCollection 2022.
- Results publication: PubMed 38860215Kapural L, Melton J, Kim B, Mehta P, Sigdel A, Bautista A, Petersen EA, Slavin KV, Eidt J, Wu J, Elshihabi S, Schwalb JM, Garrett HE Jr, Veizi E, Barolat G, Rajani RR, Rhee PC, Guirguis M, Mekhail N. Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain. J Pain Res. 2024 Jun 6;17:2001-2014. doi: 10.2147/JPR.S463727. eCollection 2024.
- Results publication: PubMed 39320284Kapural L, Kim B, Eidt J, Petersen EA, Schwalb JM, Slavin KV, Mekhail N. Long-Term Treatment of Chronic Postamputation Pain With Bioelectric Nerve Block: Twelve-Month Results of the Randomized, Double-Blinded, Cross-Over QUEST Study. Neuromodulation. 2024 Dec;27(8):1383-1392. doi: 10.1016/j.neurom.2024.08.010. Epub 2024 Sep 24.
- Derived from this study: PubMed 42057742Kapural L, Pullen J, Hargus NJ. High-frequency nerve block treatment for chronic post-amputation pain over 12 months: plain language summary of the QUEST trial. Pain Manag. 2026 Jul;16(7):685-702. doi: 10.1080/17581869.2026.2653162. Epub 2026 Apr 30.
- Neuros HFNB Pilot Study - AbstractLink provided by the sponsor.
- QUEST 3-month (Primary) RCT OutcomesLink provided by the sponsor.
- QUEST 12-month (Secondary) Long Term OutcomesLink provided by the sponsor.
- QUEST Study DesignLink 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. This study is not recruiting at the moment.
Leonardo Kapural, MD, PhD principal investigator
Center for Clinical Research, Winston-Salem NC
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altius in people with Post-Amputation Pain and Phantom Limb Pain, run by Neuros Medical, Inc. at 22 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Yes. Results are posted in the registry (first posted 11 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline (time frame: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221934, which also lists 5 linked publications.
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 6 Jun 2025.