Neuromodulation Parameter Efficacy | NCT04933370

Studies
Neuromodulation Parameter Efficacy

NCT04933370

Sponsor

Alberta Health Services, Calgary

Status

Recruiting

Last Update Posted

Aug 7, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

Stimulation parameters

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

May 28, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2024

Last Update Posted Date

Aug 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Industry standard stimulation	Active Comparator	Industry standard stimulation settings	Other: Stimulation parameters
Experimental stimulation	Sham Comparator	Experimental stimulation settings	Other: Stimulation parameters

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stimulation parameters	Other	Different device stimulation parameters	Experimental stimulation Industry standard stimulation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-English speaking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fady Girgis, MD	Contact	4039446497		fmgirgis@ucalgary.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary	Recruiting	Calgary	Alberta	T2N2T9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided