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| ID | Type | Description | Link |
|---|---|---|---|
| 25.03521.000408 | Registry Identifier | SI RIPH 2G |
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The goal of this clinical trial is to study the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on resting-state brain functional connectivity. The study will assess this effect using functional Near-Infrared Spectroscopy (fNIRS) in both chronic post-stroke patients and healthy subjects.
The main questions it aims to answer are:
Does taVNS affect resting-state functional connectivity (measured by fNIRS) in chronic post-stroke patients?
Does taVNS affect resting-state functional connectivity (measured by fNIRS) in healthy subjects?
Are there differences in the effect of taVNS on functional connectivity between the post-stroke group and the healthy group?
Researchers will compare the effect of active taVNS (real stimulation) to a sham stimulation (control) to evaluate its specific impact on the brain's functional networks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active taVNS arm | Experimental | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Delivery of low-intensity electrical impulses to the outer ear (concha and tragus) to stimulate the auricular branch of the vagus nerve. |
|
| Sham Control arm | Sham Comparator | Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active taVNS arm | Device | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Delivery of low-intensity electrical impulses to the outer ear (concha and tragus) to stimulate the auricular branch of the vagus nerve. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-State Functional Connectivity | Day 1 |
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Inclusion Criteria for post-stroke participant:
Inclusion Criteria for healthy participant:
Exclusion Criteria for post-stroke participant:
Exclusion Criteria for post-stroke participant:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Les Trois Soleils | Boissise-le-Roi | 77310 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham Control arm | Device | Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |