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

This study is currently recruiting participants.
Verified November 2013 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: November 21, 2013
Last verified: November 2013
  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 End of Treatment (EOT) [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ 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 of stimulation ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 2-weeks of stimulation ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 3-weeks of stimulation ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: End of treatment (4-weeks of Stimulation) ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 1-week post-treatment ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 4-weeks post-treatment ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates [ Time Frame: 12-weeks post-treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline Pain Interference at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Durability of change from baseline Pain Intensity at 12-weeks beyond Treatment [ Time Frame: Baseline, 12-weeks post-treatment ] [ Designated as safety issue: No ]
  • Durability of change from baseline Pain Interference at 12-weeks beyond Treatment [ Time Frame: Baseline, 12-weeks post-treatment ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change at End of Treatment [ Time Frame: End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change from Baseline Average Residual Limb Pain Intensity at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change from Baseline Average Phantom Limb Pain Intensity at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change from Baseline Worst Residual Limb Pain Intensity at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change from Baseline Worst Phantom Limb Pain Intensity at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change in Pain Analgesic Usage at End of Treatment [ Time Frame: End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change from Baseline Depression (BDI-II) at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change from Baseline Pain Disability at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]
  • Change from Baseline Prosthetic usage at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Stimulation) ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: October 2013
Estimated Primary Completion Date: April 2014 (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 location 1 in the upper leg. These subjects will then use the Smartpatch Peripheral Nerve Stimulation (PNS) System and will receive electrical 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
Experimental: Smartpatch Group 2
Subjects in Group 2 will have Smartpatch Lead(s) placed in the residual limb in location 2 in the upper leg. These subjects will use the Smartpatch Peripheral Nerve Stimulation (PNS) System and will receive electrical 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
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: November 21, 2013
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
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014