Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Alabama at Birmingham

About this trial

The purpose of this study is to find out whether a type of gentle nerve stimulation, called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the body regulates heart rate and blood pressure in people with Parkinson's Disease (PD). Problems with heart rate and blood pressure control are common and can make it harder for people to exercise or do daily activities. By using this non-invasive form of nerve stimulation and testing how it affects the body's natural responses, this study hopes to learn if taVNS could be a helpful tool to support physical therapy and improve overall function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of idiopathic PD

Stable medication for at least 4 weeks prior to the study

Disqualifiers

Use of beta blockers

Sustained severe hypertension (>/= 180/110 mmHg while seated)

Significant uncontrolled cardiac arrhythmia

Unstable angina

Trial design

Design model

Crossover

Treatments tested in this trial

  • transcutaneous auricular vagus nerve stimulation

    Device

    Participants will sit quietly while receiving active nerve stimulation for 15 minutes. A gentle electrical current is delivered through hydrogel electrodes placed in the ear. The active stimulation parameters are set to 30 Hz, 250 µs, and 0.1-4 mA.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in heart rate

Assessment of how the body adjusts heart rate during taVNS and during physical challenges. Tests include the Valsalva maneuver (blowing into a mouthpiece for 15 seconds), deep breathing test (breathing deeply and evenly at a rate of 6 breaths/minute), lying-to-standing heart rate and blood pressure tests, and an isometric handgrip test (sustaining a handgrip contraction on a dynamometer at 30% maximal effort for 5 minutes). Heart rate is continuously monitored using a Polar HR monitor.

Time frame
During Visit 2 and Visit 3 (1-2 weeks after baseline, with 48 hour wash-out between visits 2 and 3), during and following 15 minutes of stimulation.
2

Change in blood pressure

Assessment of how the body adjusts blood pressure during taVNS and during physical challenges. Tests include the Valsalva maneuver (blowing into a mouthpiece for 15 seconds), deep breathing test (breathing deeply and evenly at a rate of 6 breaths/minute), lying-to-standing heart rate and blood pressure tests, and an isometric handgrip test (sustaining a handgrip contraction on a dynamometer at 30% maximal effort for 5 minutes). Blood pressure is measured manually using a sphygmomanometer.

Time frame
During Visit 2 and Visit 3 (1-2 weeks after baseline, with 48 hour wash-out between visits 2 and 3), during and following 15 minutes of stimulation.

Secondary outcomes

1

Skin temperature

Infrared thermography will be used to assess facial, hand, and foot skin temperature.

Time frame
Before, during and immediately after both active and sham taVNS.
2

Autonomic Symptom Burden (COMPASS-31)

The Composite Autonomic Symptom Score 31 (COMPASS-31) is a validated, self-assessment questionnaire used to evaluate the severity and distribution of autonomic nervous system symptoms.Scores from each domain are weighted and summed to calculate a final Total Score. The Total Score ranges from 0 to 100. A higher score indicates a greater severity and wider distribution of autonomic symptoms (worse autonomic function), while a lower score indicates fewer and less severe autonomic symptoms (better autonomic function).

Time frame
Baseline (Visit 1)
3

Autonomic Symptom Severity (SCOPA-AUT)

The Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction (SCOPA-AUT) is a self-administered questionnaire specifically developed to assess autonomic symptoms in individuals with Parkinson's disease. The questionnaire evaluates the frequency of problems experienced over the past month. Each item is scored on a 4-point Likert scale ranging from 0 ("never") to 3 ("often"). The Total Score is calculated by summing the responses of the 23 applicable items, with a possible range from 0 to 69. A higher score indicates a greater frequency and severity of autonomic dysfunction (worse autonomic functioning), while a lower score indicates fewer autonomic symptoms (better autonomic functioning).

Time frame
Baseline (Visit 1)
4

Physical Activity (Goodin Leisure-Time Exercise Questionnaire)

The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a brief, validated self-report instrument that assesses an individual's usual physical activity habits over a typical 7-day period. The questionnaire consists of 3 items asking participants to report the number of times per week they engage in physical activities lasting more than 15 minutes across three specific intensity levels. The Weekly Leisure-Time Activity Score is calculated by multiplying the reported weekly frequencies by their respective Metabolic Equivalent (MET) values and summing the results using the following formula: (9 x Strenuous) + (5 x Moderate) + (3 x Light). The minimum possible score is 0, and there is no theoretical maximum upper limit. A higher score indicates a greater volume and intensity of weekly physical activity (better physical activity level). Clinically, a score of 24 or higher is classified as "Active," 14 to 23 as "Moderately Active," and less than 14 as "Insufficiently Active/Sedentary".

Time frame
Baseline (Visit 1)

Other outcomes

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