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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
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.
Neurorecovery Research Center, TIRR MHH
Houston, Texas, United States
RECRUITINGThe University of Texas Health Science Center at Houston
Houston, Texas, United States
NOT_YET_RECRUITINGSafety as assessed by number of subjects with change in systolic blood pressure
Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in diastolic blood pressure
Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in heart rate
Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in respiratory rate
Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in autonomic dysreflexia
Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with worsening spasticity
Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in pain at stimulation site
Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of adverse events that occurred during the study period
Time frame: 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.
80% adherence rate is defined as completing ≥ 16 out of 18 sessions
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Time frame: 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
Time frame: 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
Time frame: from baseline through completion of 18 sessions (about 6-8 weeks)
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: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]