Trial · NCT05102591
A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents
NCT05102591, Phase 3, Completed, University of Calgary; results first posted 2025-03-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents. Trials, record NCT05102591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05102591
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents
- NCT number
- NCT05102591
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- University of Calgary
- Conditions
- Migraine Disorders
- Interventions
- Ketorolac, Metoclopramide, Active Remote Electrical Neuromodulation Device, Placebo, Sham Remote Electrical Neuromodulation Device
- First posted
- 2021-11-01
- Last updated
- 2025-03-12
- Results first posted
- 2025-03-12
- Limitations and caveats
Our study was conducted during the COVID19 pandemic, the Fall of 2022 tripledemic, and a shiga-toxin E. Coli outbreak. These events hampered recruitment and our recruitment estimate is likely lower than what we anticipate under 'normal' conditions. Due to delays in the approval process, we had a shorter crossover than the parallel-group phase (9 vs. 15 months). Lastly, 90% of our study participants were White, as such the generalizability of our results is limited.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Recruitment Rate | Evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study) | The primary outcome for this pilot study involves assessment of the feasibility of using the REN device to treat children and adolescents suffering from acute migraine attacks in the ED. The primary feasibility outcome will be determined based on the recruitment rate, defined as the number of participants enrolled per month. Our target is to have an average recruitment rate of 1.5 participants per month. Feasibility will be used as the primary outcome, along with the secondary outcomes, to provide preliminary data to help design and optimize a fully powered, phase III RCT. Recruitment rate for both phases of the study are reported to understand if changing to crossover design improved recruitment. We switched to a crossover design strictly to address participant and recruitment concerns around not receiving standard of care migraine treatment if initially randomized to receive REN treatment and such treatment was unsuccessful. |
| Secondary | Reduction in Pain Severity | Difference between baseline and 1 hour, 2 hours, and 48 hours post-intervention. | Reduction in pain severity between baseline and 1-hour, 2 hours, and 48 hours post-interventions. Pain measured on an 11-point Likert scale where 0 = no pain and 10 = worst pain possible, with lower values indicating no/less pain and higher values indicating more pain. Headache pain was only assessed at 48 hours if participants indicated they were currently experiencing a headache and the 48 hours reduction in pain severity outcome does not include participants who crossed over and were exposed to both interventions as we expected them to become unblinded after being exposed to both study treatments; Standard of Care (Initial Treatment) n = 7, REN (Initial Treatment) n = 5. |
| Secondary | Number of Eligible Participants Who Are Screened, Enrolled, and Complete All Assessments | Evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study) | This secondary feasibility outcome involves the following: The number of participants who complete all assessments at each time point (baseline, 60, 120 minutes or at discharge if before 120 minutes, and 48-hours; for both the initial assigned intervention and the crossover intervention where applicable). |
| Secondary | Global Impression of Change | Evaluated for each participant at 2-hours post-intervention, and 48-hours post-intervention | This acceptability outcome involves the following: * The proportion of participants who report a global impression of change as "very much improved" or "much improved". * Measured on a 7-point Likert scale (Patient Global Impression scale in clinical status; PGI-C) where 1 = "Very much improved", 4 = "No change", and 7 = "Very much worse" * Smaller values indicate improvement of overall change while larger values indicate worsening of overall change. |
| Secondary | Study Feedback From Participants and Staff | Participant feedback evaluated at 48 hours post-intervention | This acceptability outcome involves the following: \- Participant feedback regarding study acceptability. Participant feedback measured on 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), where higher values indicate agreement and lower values indicate disagreement. Feedback questions related to study treatments is reported for both treatment groups and combined across treatment groups. Feedback questions related to the research staff and overall study experience is only combined and reported across both groups, rather than being reported for each group separately since these questions don't relate to specific study treatments. Feedback from clinical staff was collected after each participant's enrollment but not analyzed as this feedback was free-form and not collected using a scale. |
| Secondary | Number of Participants Reporting Pain Freedom | 2 hours post-intervention | Number of participants who indicated they were pain free 2-hours post-intervention. Pain measured on an 11-point Likert scale where 0 = no pain and 10 = worst pain possible, with lower values indicating no/less pain and higher values indicating more pain. |
| Secondary | Number of Participants Reporting Sustained Pain Freedom | 48 hours post-intervention | Number of participants who indicated they were pain free 2-hours post-intervention and again 48-hours post-intervention. Pain measured on an 11-point Likert scale where 0 = no pain and 10 = worst pain possible, with lower values indicating no/less pain and higher values indicating more pain. |
| Secondary | Numbers of Participants Reporting a Change in 4-point Pain Severity Scale Between Baseline and 2 Hours Post-intervention | 2 hours post-intervention | Number of participants who experienced a pain reduction from "severe" or "moderate" severity down to a "mild" or "no pain" severity, or those participants who experienced a pain reduction from "mild" to "no pain" severity between baseline and 2 hours post-intervention. Measured using the 4-point pain severity scale where 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Smaller values indicate no/less severe pain and higher values indicate more severe pain. |
| Secondary | Number of Participants Reporting Sustained Pain Relief | 48 hours post-intervention | Change from baseline "moderate" to "severe pain" to "mild or "no pain", or change from baseline "mild pain" to "no pain" 2 hours post-intervention, which is sustained to 48 hours post-intervention. Measured using the 4-point pain severity scale where 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Smaller values indicate no/less severe pain and higher values indicate more severe pain. Participants who reported they did not have a headache between 2 hours and 48 hours post-intervention were not asked to rate their pain severity and were considered to have no headache pain at 48 hours. |
| Secondary | Number of Participants Reporting Adverse Events | Evaluated from time of intervention to 2 hours and 48 hours post-intervention | The number of participants who reported experiencing adverse events and serious adverse events following intervention |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assessment of Recruitment Rate | Evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study) | Number of participants who were screened, deemed eligible, and subsequently enrolled. Three (3) participants during the parallel-group design phase withdrew after consent but before being randomized/receiving study treatments. No other participants withdrew during the study. | participants per month | MEAN |
| SECONDARY | Reduction in Pain Severity | Difference between baseline and 1 hour, 2 hours, and 48 hours post-intervention. | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | units on a scale | MEAN |
| SECONDARY | Number of Eligible Participants Who Are Screened, Enrolled, and Complete All Assessments | Evaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study) | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Global Impression of Change | Evaluated for each participant at 2-hours post-intervention, and 48-hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | participants | NUMBER |
| SECONDARY | Study Feedback From Participants and Staff | Participant feedback evaluated at 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | units on a scale | MEAN |
| SECONDARY | Number of Participants Reporting Pain Freedom | 2 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Sustained Pain Freedom | 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Numbers of Participants Reporting a Change in 4-point Pain Severity Scale Between Baseline and 2 Hours Post-intervention | 2 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Sustained Pain Relief | 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Adverse Events | Evaluated from time of intervention to 2 hours and 48 hours post-intervention | Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group89
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessment of Recruitment Rate | Parallel-group Design | 1.1 | Standard Deviation 1.5 | participants per month | |
| Assessment of Recruitment Rate | Crossover Design | 0.6 | Standard Deviation 1.0 | participants per month | |
| Reduction in Pain Severity | Standard-of-Care IV (Initial Treatment; Parallel and Crossover Phases) | 1 hour post-intervention | 2.9 | Standard Deviation 2.9 | units on a scale |
| Reduction in Pain Severity | REN (Initial Treatment; Parallel and Crossover Phases) | 1 hour post-intervention | 2.1 | Standard Deviation 1.3 | units on a scale |
| Reduction in Pain Severity | Standard-of-Care IV (Crossover Treatment; Crossover Phase) | 1 hour post-intervention | 3 | Standard Deviation 0 | units on a scale |
| Reduction in Pain Severity | Standard-of-Care IV (Initial Treatment; Parallel and Crossover Phases) | 2 hours post-intervention | 4 | Standard Deviation 3.5 | units on a scale |
| Reduction in Pain Severity | REN (Initial Treatment; Parallel and Crossover Phases) | 2 hours post-intervention | 2.4 | Standard Deviation 1.6 | units on a scale |
| Reduction in Pain Severity | Standard-of-Care IV (Crossover Treatment; Crossover Phase) | 2 hours post-intervention | 3.5 | Standard Deviation 0.7 | units on a scale |
| Reduction in Pain Severity | Standard-of-Care IV (Initial Treatment; Parallel and Crossover Phases) | 48 hours post-intervention | 3.3 | Standard Deviation 2.7 | units on a scale |
| Reduction in Pain Severity | REN (Initial Treatment; Parallel and Crossover Phases) | 48 hours post-intervention | 2.6 | Standard Deviation 1.5 | units on a scale |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard-of-Care IV Group (Parallel Design Phase) | 7 | |
| Overall Study | STARTED | REN Group (Parallel Design Phase) | 7 | |
| Overall Study | STARTED | Standard-of-Care IV Group First, Then REN Group if Applicable (Crossover Design Phase) | 3 | |
| Overall Study | STARTED | REN Group First, Then Standard-of-Care IV Group First if Applicable (Crossover Design Phase) | 2 | |
| Overall Study | COMPLETED | Standard-of-Care IV Group (Parallel Design Phase) | 7 | |
| Overall Study | COMPLETED | REN Group (Parallel Design Phase) | 7 | |
| Overall Study | COMPLETED | Standard-of-Care IV Group First, Then REN Group if Applicable (Crossover Design Phase) | 3 | |
| Overall Study | COMPLETED | REN Group First, Then Standard-of-Care IV Group First if Applicable (Crossover Design Phase) | 2 | |
| Overall Study | NOT COMPLETED | Standard-of-Care IV Group (Parallel Design Phase) | 0 | |
| Overall Study | NOT COMPLETED | REN Group (Parallel Design Phase) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Akathisia | Nervous system disorders | Standard-of-Care IV (Initial Treatment; Parallel and Crossover Phases) | 1 | 10 | 1 |
| other | Akathisia | Nervous system disorders | REN (Initial Treatment; Parallel and Crossover Phases) | 0 | 9 | 0 |
| other | Akathisia | Nervous system disorders | Standard-of-Care IV (Crossover Treatment; Crossover Phase) | 0 | 2 | 0 |
| other | Akathisia | Nervous system disorders | REN (Crossover Treatment; Crossover Phase) | 0 | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard-of-Care IV (Initial Treatment; Parallel and Crossover Phases) | 0 | 10 |
| Total, all-cause mortality | REN (Initial Treatment; Parallel and Crossover Phases) | 0 | 9 |
| Total, all-cause mortality | Standard-of-Care IV (Crossover Treatment; Crossover Phase) | 0 | 2 |
| Total, all-cause mortality | REN (Crossover Treatment; Crossover Phase) | 0 | 0 |
| Total, other adverse events | Standard-of-Care IV (Initial Treatment; Parallel and Crossover Phases) | 1 | 10 |
| Total, other adverse events | REN (Initial Treatment; Parallel and Crossover Phases) | 0 | 9 |
| Total, other adverse events | Standard-of-Care IV (Crossover Treatment; Crossover Phase) | 0 | 2 |
| Total, other adverse events | REN (Crossover Treatment; Crossover Phase) | 0 | 0 |
| Total, serious adverse events | Standard-of-Care IV (Initial Treatment; Parallel and Crossover Phases) | 0 | 10 |
| Total, serious adverse events | REN (Initial Treatment; Parallel and Crossover Phases) | 0 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39290050 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05102591
GET https://conductscience.org/api/trials/v1/NCT05102591/results?page=2