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| Name | Class |
|---|---|
| Mission Connect | UNKNOWN |
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The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with upper-limb rehabilitation in adults with tetraplegia caused by cervical spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Device | Participants will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired taVNS over six weeks, followed by a 90-day home exercise program. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by number of subjects with change in systolic blood pressure | Immediately after completing in-clinic 18 sessions (6-8 weeks) | |
| Safety as assessed by number of subjects with change in diastolic blood pressure | Immediately after completing in-clinic 18 sessions (6-8 weeks) | |
| Safety as assessed by number of subjects with change in heart rate | Immediately after completing in-clinic 18 sessions (6-8 weeks) | |
| Safety as assessed by number of subjects with change in respiratory rate | Immediately after completing in-clinic 18 sessions (6-8 weeks) | |
| Safety as assessed by number of subjects with change in autonomic dysreflexia | Immediately after completing in-clinic 18 sessions (6-8 weeks) | |
| Safety as assessed by number of subjects with worsening spasticity | Immediately after completing in-clinic 18 sessions (6-8 weeks) | |
| Safety as assessed by number of subjects with change in pain at stimulation site | Immediately after completing in-clinic 18 sessions (6-8 weeks) | |
| Safety as assessed by number of adverse events that occurred during the study period | post therapy 30 days | |
| Feasibility as assessed by the number of treatment sessions attended by each participant . The intervention is considered feasible if at least 80% adherence rate is achieved and no serious adverse events occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assessment | The 3 measured domains are as follows:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radha Korupolu, MD | Contact | 713-797-5233 | Radha.Korupolu@uth.tmc.edu | |
| Shrasti Lohiya | Contact | (713) 797-7132 | Shrasti.Lohiya@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Radha Korupolu | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurorecovery Research Center, TIRR MHH | Recruiting | Houston | Texas | 77030 | United States |
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80% adherence rate is defined as completing ≥ 16 out of 18 sessions |
| from baseline through completion of 18 sessions (about 6-8 weeks) |
| Feasibility as assessed by the participants' perceptions of the study procedures | This includes implementation using the paired taVNS with rehabilitation. This is numerically rated from 'not difficult at all' at 0, and 'very difficult' at 10, higher score indicating worse outcome | from baseline through completion of 18 sessions (about 6-8 weeks) |
| Feasibility as assessed by the participants' perceptions of the usefulness of the intervention | This is numerically rated from ''not at all useful' at 0 and 'very useful' at 10 , higher score indicating better outcome | from baseline through completion of 18 sessions (about 6-8 weeks) |
| Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] |
| Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT) | This is a 14 item questionnaire and each is scored from 1(no movement elicited) to 8(normal grasp) a higher number indicating better hand function | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] |
| Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q) | This is a 17 item questionnaire and each is scored from 1(totally limited) to 7(not at all limited), a higher number indicating better outcome | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] |
| Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore | This is a 4 item questionnaire and each is scored from 0(need total assistance) to 3(completely independent), higher score indicating more independence. | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] |
| Change in Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire | This questionnaire has 3 parts: basic mobility: this is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating more mobility Fine Motor: This is a 9 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome self care: This is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] |
| Change in Pain as assessed by the International SCI pain basic data subset (version 2) | This is an 6 item questionnaire and each is scored from 0 (no pain) -10 (pain as bad as you can imagine), a higher score indicating more pain. | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] |
| Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8) | This is an eight item questionnaire and each is scored from 0(not at all) to 3(nearly every day) a higher score indicating worse outcome | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] |
| The University of Texas Health Science Center at Houston | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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