Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by NDI Medical, LLC
Sponsor:
Collaborators:
SPR Therapeutics, LLC
United States Department of Defense
Information provided by (Responsible Party):
NDI Medical, LLC
ClinicalTrials.gov Identifier:
NCT01996254
First received: November 18, 2013
Last updated: May 31, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Condition Intervention Phase
Post-Amputation Pain
Phantom Limb Pain
Residual Limb Pain
Device: SPRINT Peripheral Nerve Stimulation (PNS) System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Pilot Study of the SPRINT Peripheral Nerve Stimulation (PNS) System for the Treatment of Post-Amputation Pain

Further study details as provided by NDI Medical, LLC:

Primary Outcome Measures:
  • Change from Baseline Pain Intensity at 4-weeks Post Lead Placement [ Time Frame: Baseline, Visit 7 (4-weeks Post Lead Placement) ] [ Designated as safety issue: No ]
  • Device related adverse event rates [ Time Frame: 24-48 hours of stimulation ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 1-week Post Lead Placement ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 2-weeks Post Lead Placement ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 3-weeks Post Lead Placement ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 4-weeks Post Lead Placement ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 5-weeks Post Lead Placement ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 6-weeks Post Lead Placement ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 7-weeks Post Lead Placement ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: End of Treatment/(8-weeks Post Lead Placement) ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 1-week Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 4-weeks Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 2-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 3-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 4-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 5-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 6-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 7-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 8-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 9-months Post EOT ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 10-months Post EOT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Durability of the treatment effect for average pain intensity after 8-week home trial [ Time Frame: Baseline, End of Treatment (8-weeks Post Lead Placement) ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 4-weeks Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 2-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 3-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 4-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 5-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 6-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 7-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 8-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 9-months Post EOT ] [ Designated as safety issue: No ]
  • Durability of the treatment effect for average pain intensity at monthly intervals after start of therapy (3-12 months after start) [ Time Frame: Baseline, 10-months Post EOT ] [ Designated as safety issue: No ]
  • Pain interference at monthly intervals after start of therapy [ Time Frame: Baseline, 4-weeks Post Lead Placement, EOT, 4-weeks Post EOT, 2-months Post EOT, 3-months Post EOT, 4-months Post EOT, 5-months Post EOT, 6-months Post EOT, 7-months Post EOT, 9-months Post EOT, 10-months Post EOT ] [ Designated as safety issue: No ]
  • Pain disability at monthly interval after start of therapy [ Time Frame: Baseline, 4-weeks Post Lead Placement, EOT, 4-weeks Post EOT, 2-months Post EOT, 3-months Post EOT, 4-months Post EOT, 5-months Post EOT, 6-months Post EOT, 7-months Post EOT, 8-months Post EOT, 9-months Post EOT, 10-months Post EOT ] [ Designated as safety issue: No ]
  • Depression at monthly intervals after start of therapy [ Time Frame: Baseline, 4-weeks Post Lead Placement, EOT, 4-weeks Post EOT, 2-months Post EOT, 3-months Post EOT, 4-months Post EOT, 5-months Post EOT, 6-months Post EOT, 7-months Post EOT, 8-months Post EOT, 9-months Post EOT, 10-months Post EOT ] [ Designated as safety issue: No ]
  • Analgesic Usage [ Time Frame: Baseline, 4-weeks Post Lead Placement, 8-weeks Post Lead Placement ] [ Designated as safety issue: No ]
  • Prosthetic Usage [ Time Frame: Baseline, 4-weeks Post Lead Placement, 8-weeks Post Lead Placement ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: October 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPRINT Group 1
Subjects in Group 1 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
Device: SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Other Names:
  • SPRINT System, SPRINT
  • Smartpatch System, Smartpatch
Sham Comparator: SPRINT Group 2
Subjects in Group 2 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System for a total of 8 weeks. They will receive 4 weeks of stimulation and 4 weeks with no stimulation.
Device: SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Other Names:
  • SPRINT System, SPRINT
  • Smartpatch System, Smartpatch

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • At least 18 years old
  • Traumatic lower extremity amputation(s)
  • Healed amputation and healthy residual limb based upon the investigator's evaluation

Key Exclusion Criteria:

  • Change of prescribed medications affecting pain within the past 4 weeks
  • Compromised immune system based on medical history
  • Implanted electronic device
  • Bleeding disorder
  • History of valvular heart disease
  • Confounding central nervous system injuries and disorders
  • History of recurrent skin infections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996254

Locations
United States, California
University of California San Diego Active, not recruiting
La Jolla, California, United States, 92093
United States, Colorado
Denver Clinic for Extremities at Risk Recruiting
Denver, Colorado, United States, 80218
Contact: Libby Mauter       libby.mauter@gmail.com   
Principal Investigator: Giancarlo Barolat, MD         
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Connie Kurihara    301-295-4455    connie.kurihara.civ@mail.mil   
Principal Investigator: Richard Liu, MD         
United States, New York
Ainsworth Institute of Pain Management Recruiting
New York, New York, United States, 10022
Contact: Lisa Molina    212-203-2813    emolina@ainpain.com   
Principal Investigator: Cory Hunter, MD         
United States, North Carolina
Center for Clinical Research Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Jamie Southern    336-765-6181    JSouthern@ccrpain.com   
Principal Investigator: Richard Rauck, MD         
Sponsors and Collaborators
NDI Medical, LLC
SPR Therapeutics, LLC
United States Department of Defense
Investigators
Principal Investigator: Josh Boggs, PhD NDI Medical
  More Information

Additional Information:
Responsible Party: NDI Medical, LLC
ClinicalTrials.gov Identifier: NCT01996254     History of Changes
Other Study ID Numbers: 0123-CSP-000 
Study First Received: November 18, 2013
Last Updated: May 31, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by NDI Medical, LLC:
electrical stimulation
neurostimulation
neuromodulation
post-amputation pain
phantom limb pain
residual limb pain
neuropathic pain
amputee pain

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2016