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CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies

NCT02986074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-03

Study results available
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Summary

The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.

Conditions

Interventions

DEVICE

Paresthesia mapping lead evaluation first

Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial

DEVICE

Anatomical midline lead evaluation first

Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial

Sponsors & Collaborators

  • St Thomas

    collaborator AMBIG

  • Seacroft Hospital

    collaborator OTHER

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Lalit Venkatesan, Ph.D. · Abbott Medical Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-08-19
Completion
2019-08-19

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02986074 on ClinicalTrials.gov