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Trial record 3 of 3430 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation (FOCAL)

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ClinicalTrials.gov Identifier: NCT04073446
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To evaluate programming modalities at various targets for focal foot pain relief.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Spinal Cord Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Dorsal Column (DC) Perception
Use of DC Perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS

Active Comparator: Dorsal Root (DR) Perception
Use of DR Perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS

Active Comparator: Dorsal Column (DC) Sub-perception
Use of DC sub-perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS

Active Comparator: Dorsal Root (DR) Sub-perception
Use of DR sub-perception based programming
Device: Spinal Cord Stimulation
Patients eligible for SCS




Primary Outcome Measures :
  1. Change in overall pain intensity [ Time Frame: up to 1.5 year post implant ]
    Change in overall pain intensity from Baseline to end of each Period and End of Study (NRS)



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

Key Inclusion Criteria:

  • Average unilateral foot pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score
  • Subject signed a valid, EC-approved informed consent form (ICF)
  • Willing and able to comply with all protocol-required procedures and assessments/evaluations
  • 18 years of age or older when written informed consent is obtained

Key Exclusion Criteria:

  • Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
  • Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073446


Contacts
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Contact: Diane Keesey 661-949-4175 Diane.Keesey@bsci.com
Contact: Roshini Jain 661-949-4350 roshini.jain@bsci.com

Locations
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United States, California
Boston Scientific Clinical Research Recruiting
Valencia, California, United States, 98040
Contact: Roshini Jain         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Corporation

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04073446     History of Changes
Other Study ID Numbers: A4068
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: July 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 Boston Scientific Corporation:
Spinal Cord Stimulation
Chronic Pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms