Electrical Nerve Block for Amputation Pain

Phantom Limb Pain Clinical Trial

Official title:

High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02221934
• Other study ID #: 003-0001
• Secondary ID: QUEST Trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2014
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Neuros Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 607
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain
• Post-Amputation Pain
• Residual Limb Pain
• Stump Pain

Intervention

Device:
• Altius
Electrical signal

Locations

Country	Name	City	State
United States	Emory University / Grady Hospital	Atlanta	Georgia
United States	Legacy Brain & Spine LLC	Atlanta	Georgia
United States	University of Illinois Chicago	Chicago	Illinois
United States	Cleveland Clinic Pain Management	Cleveland	Ohio
United States	Baylor Scott and White Research Institute	Dallas	Texas
United States	Meta Medical Research Institute	Dayton	Ohio
United States	HCA Healthcare Research Institute / St. Luke's Presbyterian	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Arkansas for Medical Sciences (UAMS)	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	Drug Studies America	Marietta	Georgia
United States	Cardiovascular Surgery Clinic	Memphis	Tennessee
United States	The Surgical Clinic	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Advanced Surgical and Research Solutions	Oklahoma City	Oklahoma
United States	Nona Medical Arts	Orlando	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Arizona Pain Institute	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Kettering Medical Center	Springboro	Ohio
United States	Baylor Scott and White - Temple Memorial Vascular Surgery	Temple	Texas
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Neuros Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Efficacy: Prosthetic Use	Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.	12 months post implant
Primary	Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline	Demonstration of 50% reduction in a Numerical Rating Scale (NRS) 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).	Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Primary	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.	From screening injection visit through 3 months post implant
Secondary	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	12 months post implant
Secondary	Secondary Effectiveness: Pain Days Per Week	Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.	12 months post implant
Secondary	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.	12 months post implant
Secondary	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.	12 months post implant
Secondary	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.	12 months post implant
Secondary	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	12 months post implant
Secondary	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.	12 months post implant

External Links

•   Neuros HFNB Pilot Study - Abstract