Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being. We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
tDCS is a noninvasive brain stimulation device that modulates brain activity delivering a low-intensity electrical current.
taVNS is a noninvasive peripheral nerve stimulation device that modulates vagus nerve activity delivering a low-intensity electrical current (\< 5mA) through hydrogel electrodes to the left auricular branch of the vagus nerve.
tcVNS is a noninvasive peripheral nerve stimulation device that modulates vagus nerve activity delivering a low-intensity electrical current (\< 5mA) through cervical hydrogel electrodes to the left cervical branch of the vagus nerve.
NYU Langone Health
New York, New York, United States
RECRUITINGPercentage of Participants who Complete Home-Based taVNS or tcVNS Sessions
Assessed among participants in the taVNS or tcVNS arms only.
Time frame: Up to Week 4 (End of Intervention)
Change in SymptoMScreen Score
SymptoMScreen is a self-report tool to assess overall symptom burden.
Time frame: Baseline, Week 4 (End of Intervention)
Change in Multiple Sclerosis Impact Scale (MSIS-29) Score
12-item self-report scale to assess symptom burden regarding neurological domains and the psychological impact of MS. Each item is rated on a 7-point Likert scale from 0 to 6. The item responses are summed to calculate a total score ranging from 0 to 72, with a higher score indicating more severe symptom limitations
Time frame: Baseline, Week 4 (End of Intervention)
Change in Memorial Symptom Assessment Scale (MSAS) Score
32-item symptom self-report rating scale to better understand the symptom severity, symptom frequency, and distress from common symptoms. The total MSAS score is the average of the symptom scores for all 32 symptoms and ranges from 0 to 4. Higher scores indicate greater impact from symptoms.
Time frame: Baseline, Week 4 (End of Intervention)
Change in Kessler Psychological Distress Scale (K10) Score
10-item questionnaire to assess psychological distress over a recent period of the past 4 weeks focusing on anxiety and depressive symptoms. Each item is rated on a 5-point Likert scale from 1-5. The total score is the sum of responses and ranges from 10-50; higher scores indicate more severe mental disorder.
Time frame: Baseline, Week 4 (End of Intervention)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score
8-item qualitative self-report questionnaire regarding functions of sleep and wakefulness such as perceived sleep quality, sleep depth, and restfulness after sleep in the past 7 days. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 8-40; a higher score indicates more severe sleep disturbances.
Time frame: Baseline, Week 4 (End of Intervention)
Change in PROMIS Fatigue - Short Form 7a Score
7-item self-report tool assessing fatigue severity and impact. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 7-35; higher scores indicate greater fatigue.
Time frame: Baseline, Week 4 (End of Intervention)
Change in PROMIS Pain Intensity - Short Form 3a Score
3-item tool to evaluate quantitative participant experiences of pain intensity both over the past 7 days and at the time of completing the self-report assessment. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 3-15; higher scores indicate greater pain intensity.
Time frame: Baseline, Week 4 (End of Intervention)
Change in General Anxiety Disorder (GAD-7) Score
7-item self-report questionnaire to screen for generalized anxiety in addition to assessing severity of anxiety symptoms. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate more prevalent symptoms of anxiety.
Time frame: Baseline, Week 4 (End of Intervention)
Change in Composite Autonomic Symptom Score-31 (COMPASS-31) Score
31-item scale measuring autonomic symptoms in six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. A total score from 0-100 is generated from the item responses; higher scores indicate more severe autonomic dysfunction.
Time frame: Baseline, Week 4 (End of Intervention)
Change in Patient Health Questionnaire (PHQ-9) Score
9-item self-report questionnaire to screen for depressive disorder and furthermore, severity. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depressive symptoms.
Time frame: Baseline, Week 4 (End of Intervention)
Change in Nine-Hole Peg Test (9HPT) Score
Assessment of manual dexterity and fine motor coordination in people with MS, using both dominant and non-dominant hands. The score is measured by the number of seconds it takes for a person to place and remove nine pegs from a pegboard, with a lower score (in seconds) indicating better dexterity and faster completion time.
Time frame: Baseline, Week 4 (End of Intervention)
Change in Heart Rate Variability (HRV)
Assessed using the Chest Strap Polar H10 HR sensor.
Time frame: Baseline, Week 4 (End of Intervention)
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