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| Name | Class |
|---|---|
| National Center of Neuromodulation for Rehabilitation | OTHER |
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The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group | Experimental | This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours. |
|
| Transcranial Magnetic Stimulation (TMS) group | Active Comparator | This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS Video | Other | One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. |
| Measure | Description | Time Frame |
|---|---|---|
| Change Expectation for Pain Relief as Measured by EXPECT Scores | The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) is a 4-item questionnaire that assesses expectations for pain improvement. Each of the 4 items is scored on an 11-point scale, with 0 being no change and 10 representing complete relief (scores ranging from 0-10). Higher scores represent greater expectations for pain relief. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief. | Baseline, and up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability (HRV) | HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR). | Baseline, up to 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlon Wong | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39896735 | Derived | Wong ML, Widerstrom-Noga E, Bolanos JL, Gonzalez G, Penedo FJ, Hosein PJ, Tovin MM, Gonzalez JP, McTeague LM. Feasibility of trancutaneous auricular vagus nerve stimulation in Black and Hispanic/Latino people with peripheral neuropathy. Front Pain Res (Lausanne). 2025 Jan 17;5:1516196. doi: 10.3389/fpain.2024.1516196. eCollection 2024. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group | This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours. taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2023 |
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| Educational materials | Other | Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure. |
|
| TMS Video | Other | One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. |
|
| FG001 | Transcranial Magnetic Stimulation (TMS) Group | This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours. Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure. TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group | This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours. taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure. |
| BG001 | Transcranial Magnetic Stimulation (TMS) Group | This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours. Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure. TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Expectation for Pain Relief as Measured by EXPECT Scores | The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) is a 4-item questionnaire that assesses expectations for pain improvement. Each of the 4 items is scored on an 11-point scale, with 0 being no change and 10 representing complete relief (scores ranging from 0-10). Higher scores represent greater expectations for pain relief. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and up to 90 minutes |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Heart Rate Variability (HRV) | HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR). | Posted | Mean | Standard Deviation | Milliseconds | Baseline, up to 90 minutes |
|
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group | This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours. taVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | Transcranial Magnetic Stimulation (TMS) Group | This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours. Educational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure. TMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlon L. Wong | University of Miami | 3052842670 | mwong2@miami.edu |
| Oct 13, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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|