Neuromodulation Parameter Efficacy

August 6, 2024 updated by: Fady Girgis, Alberta Health Services, Calgary

Evaluating the Efficacy of Different Stimulation Paradigms in Neuromodulation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Different stimulation parameters will be tried in a blinded fashion to compare efficacy.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • Recruiting
        • University of Calgary
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Industry standard stimulation
Industry standard stimulation settings
Other: Stimulation parameters
Different device stimulation parameters
Sham Comparator: Experimental stimulation
Experimental stimulation settings
Other: Stimulation parameters
Different device stimulation parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline pain measures
Time Frame: 6 months
Pain outcomes measured using visual analogue scale
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of stimulation on quality of life
Time Frame: 6 months
As measured using EQ-5D-3L
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health Services, Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB21-0692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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