NCT04933370

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
2mo left

Started Feb 2022

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2022Jul 2026

First Submitted

Initial submission to the registry

May 28, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4.4 years

First QC Date

May 28, 2021

Last Update Submit

August 6, 2024

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Change in baseline pain measures

    Pain outcomes measured using visual analogue scale

    6 months

Secondary Outcomes (1)

  • Effect of stimulation on quality of life

    6 months

Study Arms (2)

Industry standard stimulation

ACTIVE COMPARATOR

Industry standard stimulation settings

Other: Stimulation parameters

Experimental stimulation

SHAM COMPARATOR

Experimental stimulation settings

Other: Stimulation parameters

Interventions

Stimulation parametersOTHER

Different device stimulation parameters

Experimental stimulationIndustry standard stimulation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N2T9, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Fady Girgis, MD

CONTACT

4039446497fmgirgis@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 21, 2021

Study Start

February 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)