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Neuromodulation Parameter Efficacy

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stimulation parameters
Sponsored by
Alberta Health Services, Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are candidates for, and have been consented for, implantation of a neuromodulation device.

Exclusion Criteria:

  • Non-English speaking

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Industry standard stimulation

Experimental stimulation

Arm Description

Industry standard stimulation settings

Experimental stimulation settings

Outcomes

Primary Outcome Measures

Change in baseline pain measures
Pain outcomes measured using visual analogue scale

Secondary Outcome Measures

Effect of stimulation on quality of life
As measured using EQ-5D-3L

Full Information

First Posted
May 28, 2021
Last Updated
July 19, 2023
Sponsor
Alberta Health Services, Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04933370
Brief Title
Neuromodulation Parameter Efficacy
Official Title
Evaluating the Efficacy of Different Stimulation Paradigms in Neuromodulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Health Services, Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine the efficacy of neuromodulation using various stimulation paradigms in the treatment of several disorders including chronic pain.
Detailed Description
Different stimulation parameters will be tried in a blinded fashion to compare efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Industry standard stimulation
Arm Type
Active Comparator
Arm Description
Industry standard stimulation settings
Arm Title
Experimental stimulation
Arm Type
Sham Comparator
Arm Description
Experimental stimulation settings
Intervention Type
Other
Intervention Name(s)
Stimulation parameters
Intervention Description
Different device stimulation parameters
Primary Outcome Measure Information:
Title
Change in baseline pain measures
Description
Pain outcomes measured using visual analogue scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effect of stimulation on quality of life
Description
As measured using EQ-5D-3L
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are candidates for, and have been consented for, implantation of a neuromodulation device. Exclusion Criteria: Non-English speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fady Girgis, MD
Phone
4039446497
Email
fmgirgis@ucalgary.ca
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fady Girgis, MD
Phone
4039446497
Email
fmgirgis@ucalgary.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuromodulation Parameter Efficacy

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