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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20GM109040 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)
This study aims to refine and develop closed loop taVNS, establish activity with key biomarkers, and show initial feasibility in a small clinical trial. For paired taVNS to succeed as a clinical treatment, it is critical to develop and refine a closed-loop taVNS platform that delivers stimulation concurrently during specific movements of the motor rehabilitation training.
Aim 1 develops this novel motion-gated closed-loop system that delivers taVNS in synchrony with specific upper limb motor activation (n=5) Aim 2 will combine the development of the closed-loop system with the investigator's mechanistic understanding to explore an open-label pilot trial (n=20) using closed-loop taVNS paired with task-specific training to determine the feasibility, safety, and potential effect size of this novel combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "paired" taVNS + Task Specific Training | Active Comparator |
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| "unpaired" taVNS + Task Specific Training | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training | Device | A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Assessment of the Upper Extremity | The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability. | Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | "Paired" taVNS + Task Specific Training | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. |
| FG001 | "Unpaired" taVNS + Task Specific Training | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Adults with unilateral motor deficits post-stroke
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| ID | Title | Description |
|---|---|---|
| BG000 | "Paired" taVNS + Task Specific Training | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. |
| BG001 | "Unpaired" taVNS + Task Specific Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 in Fugl-Meyer Assessment of the Upper Extremity | The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability. | Adults with unilateral motor deficits post-stroke | Posted | Mean | Standard Error | score on a scale | Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline |
|
1 year, 8 months
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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 | "Paired" taVNS + Task Specific Training | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bashar Badran | The Medical University of SC | 843-792-6076 | badran@musc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2021 | Nov 29, 2023 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2021 | Feb 5, 2024 | ICF_002.pdf |
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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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Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | "Unpaired" taVNS + Task Specific Training | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | "Unpaired" taVNS + Task Specific Training | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |