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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by NDI Medical, LLC
Sponsor:
Collaborators:
SPR Therapeutics, LLC
Information provided by (Responsible Party):
NDI Medical, LLC
ClinicalTrials.gov Identifier:
NCT01996254
First received: November 18, 2013
Last updated: September 30, 2014
Last verified: September 2014
  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 Smartpatch System. The Smartpatch System delivers mild electrical stimulation to nerves in the residual limb. The Smartpatch 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 Smartpatch Stimulator).


Condition Intervention Phase
Post-Amputation Pain
Phantom Limb Pain
Residual Limb Pain
Device: Smartpatch 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, Controlled, Parallel Group, Multicenter Pilot Study of the Smartpatch 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-monts 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-monts 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: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smartpatch Group 1
Subjects in Group 1 will have a Smartpatch Lead placed in the residual limb in the upper leg. These subjects will then use the Smartpatch Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
Device: Smartpatch Peripheral Nerve Stimulation (PNS) System
The Smartpatch System is an Investigational Device which delivers mild electrical stimulation to nerves in the residual limb. The Smartpatch 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 Smartpatch Stimulator).
Other Name: Smartpatch System, Smartpatch
Sham Comparator: Smartpatch Group 2
Subjects in Group 2 will have a Smartpatch Lead placed in the residual limb in the upper leg. These subjects will then use the Smartpatch 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: Smartpatch Peripheral Nerve Stimulation (PNS) System
The Smartpatch System is an Investigational Device which delivers mild electrical stimulation to nerves in the residual limb. The Smartpatch 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 Smartpatch Stimulator).
Other Name: Smartpatch System, Smartpatch

  Eligibility

Ages Eligible for Study:   18 Years and older
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, North Carolina
Center for Clinical Research Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Jamie Southern    336-765-6181      
Principal Investigator: Richard Rauck, MD         
Sponsors and Collaborators
NDI Medical, LLC
SPR Therapeutics, LLC
Investigators
Principal Investigator: Josh Boggs, PhD NDI Medical
  More Information

Additional Information:
No publications provided

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: September 30, 2014
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

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

ClinicalTrials.gov processed this record on November 25, 2014