Chronic Incomplete Cervical Spinal Cord Injury (SCI)
Conditions
Keywords
spinal cord injury (SCI), upper arm rehabilitation
Brief summary
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.
Interventions
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.
Sponsors
Mission Connect
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) * at least 12 months post-traumatic SCI but less than 10 years post-SCI * demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger sufficient to grip small objects such as marble)
Exclusion criteria
* non-traumatic SCI * recent ear trauma and skin lesions at the site of stimulation, such as sunburn, cuts, and open sores, * facial or ear pain, * allergic reaction to adhesives and electrodes, * any current or past history of cardiovascular disorders, * intracranial metal implants, pacemakers, * concomitant clinically significant brain injury, * receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry * If there is a plan for alteration in upper-extremity therapy or medication for muscle tone during the course of the study; * medical or mental instability; * pregnancy or plans to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as assessed by the participants' perceptions of the usefulness of the intervention | from baseline through completion of 18 sessions (about 6-8 weeks) | This is numerically rated from ''not at all useful' at 0 and 'very useful' at 10 , higher score indicating better outcome |
| 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 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. | from baseline through completion of 18 sessions (about 6-8 weeks) | 80% adherence rate is defined as completing ≥ 16 out of 18 sessions |
| Feasibility as assessed by the participants' perceptions of the study procedures | from baseline through completion of 18 sessions (about 6-8 weeks) | 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 |
| 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 change in heart rate | Immediately after completing in-clinic 18 sessions (6-8 weeks) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT) | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] | 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 |
| Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q) | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] | 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 |
| Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] | This is a 4 item questionnaire and each is scored from 0(need total assistance) to 3(completely independent), higher score indicating more independence. |
| Change in Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] | 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 |
| Change in Pain as assessed by the International SCI pain basic data subset (version 2) | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] | 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. |
| Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8) | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] | 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 |
| Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assessment | Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days] | The 3 measured domains are as follows: 1. Strength: Motor grading of 10 arm and hand muscles for right and left arm will be performed. Each muscle is graded from 0 to 5 for a maximum score of 50, a higher number indicating more strength. 2. Dorsal and palmar sensation: Each test location is scored from 0 to 4. Three locations for the dorsal side of each hand and 3 for palmer location of each hand are summed to render a subtest total score between 0 and 12 a higher score indicating more sensation. 3. Prehension: 1. Qualitative prehension: The participant performs 3 tasks using each hand and is scored from 0-12 a higher number indicating a better outcome 2. Quantitative prehension: he participant performs 6 tasks using each hand and is scored from 0-30 a higher number indicating a better outcome |
Countries
United States
Contacts
Primary ContactRadha Korupolu, MD
Backup ContactShrasti Lohiya
Outcome results
None listed