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PNS Post-Marketing Study (STIM-Q PMS)

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ClinicalTrials.gov Identifier: NCT03877653
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Stimwave Technologies

Brief Summary:
The purpose of this study is to assess the safety and effectiveness of the Freedom PNS (peripheral nerve stimulation) System for the treatment of chronic pain of peripheral nerve origin in trunk or limbs over a follow-up period of six months.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Wireless neuromodulation Not Applicable

Detailed Description:
The purpose of this study is to assess the safety and effectiveness of the Freedom PNS (peripheral nerve stimulation) System for the treatment of chronic pain of peripheral nerve origin in trunk or limbs over a follow-up period of six months. Investigators will have the option to select one or more stimulators for stimulation over the enervated nerve(s). Stimulation programs include tonic stimulation, high frequency stimulation or burst stimulation, all of which may be selected via the same implant. Subjects will have chronic, intractable pain of the trunk or limbs, refractory to standard medical treatment; including unilateral or bilateral pain. 23 subjects will receive the Freedom PNS System and will be monitored for a total of six months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Intervention Model Description: PMS single group, open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Post-Marketing Study of the Clinical Outcomes of Wireless Neuromodulation Via the Freedom Peripheral Nerve Stimulation (PNS) System for the Management of Chronic Trunk or Limb Pain
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Interventional
Single arm
Device: Wireless neuromodulation
A needle and catheter are carefully inserted near the enervated nerve. The stimulator is then placed through the catheter close to the nerve. The proximal end of the stimulator is then sutured underneath the skin to prevent migration.




Primary Outcome Measures :
  1. Responder rate [ Time Frame: 6 months ]
    Percentage of patients with at least 50% pain relief experienced in the area of pain identified at baseline compared to 6 months post full implant of the Freedom PNS system with the VAS

  2. Adverse Events [ Time Frame: 6 months ]
    Incidence and severity of device related adverse events during the study.


Secondary Outcome Measures :
  1. Pain VAS (Visual Analog scale) [ Time Frame: 6 months ]
    Percentage of pain relief experienced in the area of pain identified at baseline compared to 6 months post full implant of the Freedom PNS system as described on a 100 mm line scale (with 0= no pain; 100: worst pain imaginable)

  2. Pain Disability Index [ Time Frame: 6 months ]
    Improved function via the PDI questionnaires (7 questions) at 6 months compared to baseline. Answers on a scale of 0 (no disability) to 10 (worst disability)

  3. Patient Global Impression of change [ Time Frame: 6 months ]
    Patient Global impression of Change (PGIC) at 6 months compared to baseline. Scale from 1 (no change) to 7 (a great deal better) describing improvement with therapy

  4. Life Quality of life 5 lines [ Time Frame: 6 months ]
    Improved quality of life via the EQ-5D-5L questionnaire (5 questions) at 6 months. Answers on a scale of 1 (no problems) to 5 (unable)

  5. Change in Medication [ Time Frame: 6 months ]
    use of analgesics (dosage, units, schedule) at 6 months compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Appropriate Freedom PNS candidate as affirmed by study investigator;
  • 18 years of age or older (no upper age limit);
  • Diagnosis of chronic pain of peripheral nerve origin in trunk and or limbs;
  • Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain);
  • Pain duration of at least 6 months;
  • A positive diagnostic block of the enervated nerve;
  • Expected lifespan of at least two years;
  • Able to comply with study requirements;
  • Gives informed consent for study participation.

Exclusion Criteria:

  • A co-existing condition that could increase the risk of PNS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by PNS (e.g., diathermy).
  • Pregnant or planning to become pregnant, lactating;
  • Known or suspected substance abuse within the last 2 years;
  • Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion;
  • Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events);
  • Documented allergy to Freedom PNS material components;
  • Co-existing pain condition or participation in another clinical study that could confound the results of this study;
  • Based on the opinion of the investigator any legal concerns that would preclude his / her enrollment in the study or potentially confound the results;
  • Any other implanted active medical devices whether turned on or off.

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Responsible Party: Stimwave Technologies
ClinicalTrials.gov Identifier: NCT03877653     History of Changes
Other Study ID Numbers: 30-00703
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Stimwave Technologies:
PNS
Chronic
Pain
Wireless
Neuromodulation

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms