Neuromodulation Parameter Efficacy
Sponsor
Alberta Health Services, Calgary (Other)
Overall Status
Recruiting
CT.gov ID
NCT04933370
Collaborator
(none)
20
1
2
52.9
0.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Different stimulation parameters will be tried in a blinded fashion to compare efficacy.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluating the Efficacy of Different Stimulation Paradigms in Neuromodulation
Actual Study Start Date
:
Feb 1, 2022
Anticipated Primary Completion Date
:
Jul 1, 2026
Anticipated Study Completion Date
:
Jul 1, 2026
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in baseline pain measures [6 months]
Pain outcomes measured using visual analogue scale
Secondary Outcome Measures
- Effect of stimulation on quality of life [6 months]
As measured using EQ-5D-3L
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients who are candidates for, and have been consented for, implantation of a neuromodulation device.
Exclusion Criteria:
- Non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Calgary | Calgary | Alberta | Canada | T2N2T9 |
Sponsors and Collaborators
- Alberta Health Services, Calgary
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fady Girgis,
Physician,
Alberta Health Services, Calgary
ClinicalTrials.gov Identifier:
NCT04933370
Other Study ID Numbers:
- REB21-0692
First Posted:
Jun 21, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: