FOCAL: Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04073446
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 4
• Actual Duration (Months): 23
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Spinal Cord Stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 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
• Actual Study Start Date: Oct 31, 2019
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in overall pain intensity [up to 1.5 year post implant]

   Change in overall pain intensity from Baseline to end of each Period and End of Study (NRS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Average unilateral foot, or knee or groin 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Nikolaas	Sint-Niklaas		Belgium

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT04073446
• Other Study ID Numbers: A4068
• First Posted: Aug 29, 2019
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• 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: Chronic Pain

Study Results

No Results Posted as of May 9, 2022