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Synthetic Vasomotion for Glymphatic Enhancement

ConditionParkinson Disease (PD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorFlorida Institute for Human and Machine Cognition

About this trial

The goal of this pilot clinical trial is to learn whether a week-long study combining controlled breathing procedures, intermittent exposure to a low-concentration carbon dioxide gas mixture, and noninvasive vagus nerve stimulation can be carried out safely and comfortably in adults with early-stage Parkinson's disease and age-matched healthy adults. The study will also explore how these procedures affect physiological signals related to breathing, cardiovascular and autonomic function, brain activity, and physiological processes thought to be related to fluid movement in and around the brain.

The main questions the study aims to answer are:

* Can participants safely and comfortably complete the study procedures and at-home monitoring? * Do physiological responses differ when intermittent hypercapnia is paired with active noninvasive vagus nerve stimulation compared with sham stimulation? * Are changes measured during the intervention visits related to overnight physiological measurements and changes in blood-based biomarkers?

Researchers will compare active and sham noninvasive vagus nerve stimulation within the same participants. Both conditions will be paired with guided breathing and intermittent hypercapnia, in which participants briefly breathe a controlled gas mixture containing 5% carbon dioxide.

Participants will:

* Complete an intake and baseline visit and several nights of at-home physiological monitoring. * Complete two intervention visits in randomized order, one using active vagus nerve stimulation and one using sham stimulation. * Complete guided breathing and intermittent hypercapnia procedures while respiratory, cardiovascular, and other physiological signals are monitored. * Provide blood samples before and after intervention procedures for exploratory biomarker measurements.

This is an exploratory pilot study. It is not intended to diagnose, treat, or prevent Parkinson's disease or any other medical condition.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Active noninvasive vagus nerve stimulation

    Device

    Active cervical noninvasive vagus nerve stimulation (nVNS) will be delivered using the gammaCore device. Participants will receive two consecutive 2-minute stimulation applications, one on each side of the neck. Stimulation intensity will be adjusted by the participant to a perceptible but comfortable level. The device delivers 1-ms pulses of 5-kHz sine waves at 25 Hz.

  • Sham noninvasive vagus nerve stimulation

    Device

    Participants will undergo the same application procedure and duration as active nVNS using a sham device. The sham device is similar in appearance to the active device and produces vibration and audible feedback but does not deliver active electrical stimulation.

  • Active intermittent hypercapnia

    Procedure/Surgery

    Participants will intermittently breathe a controlled hypercapnic gas mixture containing approximately 5% carbon dioxide, 21% oxygen, and balance nitrogen through a noninvasive mask. The intervention consists of three approximately 10-minute hypercapnia blocks according to the study protocol, with respiratory and physiological monitoring throughout.

  • Sham intermittent hypercapnia

    Procedure/Surgery

    Participants will undergo the same mask-based breathing procedures used for the intermittent hypercapnia condition but will breathe room air rather than the hypercapnic gas mixture. This condition serves as the baseline/sham hypercapnia condition.

  • Guided breathing

    Behavioral

    Participants will complete approximately 10 minutes of guided breathing during study visits. Breathing will be standardized using verbal instruction from study personnel and/or visual or auditory pacing cues, which may include commercially available applications such as Elite HRV or study-specific pacing aids. The guided breathing procedure is intended to standardize breathing timing and pacing during physiological monitoring and intervention procedures and is not used for diagnosis, treatment, or medical decision-making.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Sequence A: Sham nVNS FirstExperimental treatment 5 interventions
Group B: Sequence B: Active nVNS FirstExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Completing the Multimodal Study Protocol

Feasibility will be assessed as the number and proportion of enrolled participants who complete the planned in-clinic visits, intervention procedures, and scheduled at-home Applied Cognition GF Monitor recordings. Reasons for incomplete procedures or study withdrawal will also be documented.

Time frame
From enrollment through completion of the approximately 1-week study protocol
2

Incidence of Study-Related Adverse Events

Safety will be assessed by the number and proportion of participants experiencing adverse events during or following study procedures. Adverse events will be documented with respect to type, severity, timing, and relationship to intermittent hypercapnia, guided breathing, nVNS, physiological monitoring, or blood collection.

Time frame
From initiation of study procedures through completion of the approximately 1-week protocol
3

Change in Participant-Reported Tolerability During Intervention Procedures

Participants will rate dizziness, stress/anxiety, and overall discomfort on 1-to-10 numeric rating scales before and after each 10-minute intermittent hypercapnia block and following completion of the overall hypercapnia protocol. Additional symptoms and tolerability concerns will also be recorded.

Time frame
During intervention visits on Days 3 and 5, before and after each 10-minute hypercapnia block and immediately after the overall hypercapnia protocol, up to 1 week
4

Proportion of Planned Physiological Recordings With Usable Data

The proportion of planned physiological recording sessions that yield usable data will be assessed across the Applied Cognition GF Monitor and respiratory, cardiovascular, and autonomic monitoring systems. Device failures, incomplete recordings, and technical problems resulting in unavailable or unusable data will be documented.

Time frame
From baseline through completion of scheduled intervention, recovery, and overnight monitoring periods, up to 1 week

Secondary outcomes

1

Change in EIS-Derived Brain Parenchymal Resistance During Intervention

Electrical impedance spectroscopy (EIS) obtained with the Applied Cognition GF Monitor will be used to quantify changes in brain parenchymal resistance across baseline, intervention, and recovery periods. Within-participant responses will be compared across the study intervention conditions.

Time frame
During each intervention visit, from pre-intervention baseline through the post-intervention recovery period, approximately 1.5-2 hours
2

Change in Overnight EIS-Derived Brain Parenchymal Resistance Following Intervention

Overnight EIS-derived brain parenchymal resistance measured following the first intervention visit will be compared with measurements obtained during the baseline overnight monitoring nights to explore intervention-associated changes in overnight physiology.

Time frame
Baseline Nights 1 and 2 compared with the overnight recording following the first intervention visit, within approximately 3 days
3

Change in Carbon Dioxide Levels During Intervention

Transcutaneous carbon dioxide and/or end-tidal carbon dioxide will be measured continuously or repeatedly during baseline, intermittent hypercapnia, and recovery to characterize the physiological response to controlled carbon dioxide exposure.

Time frame
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
4

Change in Peripheral Oxygen Saturation During Intervention

Peripheral oxygen saturation (SpO2) will be monitored during baseline, intervention, and recovery periods to characterize respiratory responses and support participant safety monitoring.

Time frame
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours

Other outcomes

1

Consensus Sleep Diary Total Sleep Time

Total sleep time will be derived from the Consensus Sleep Diary based on participant-reported sleep and wake times for the previous night.

Time frame
Each morning following scheduled study nights, up to 1 week
2

Consensus Sleep Diary Sleep Onset Latency

Sleep onset latency will be derived from the Consensus Sleep Diary as the participant-reported time from attempting to fall asleep to sleep onset.

Time frame
Each morning following scheduled study nights, up to 1 week
3

Consensus Sleep Diary Wake After Sleep Onset

Wake after sleep onset will be derived from the Consensus Sleep Diary based on participant-reported nighttime awakenings after initial sleep onset.

Time frame
Each morning following scheduled study nights, up to 1 week
4

Consensus Sleep Diary Sleep Efficiency

Sleep efficiency will be derived from the Consensus Sleep Diary as the percentage of time in bed spent asleep.

Time frame
Each morning following scheduled study nights, up to 1 week

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida Institute for Human and Machine Cognition

Lead sponsor

Applied Cognition

Collaborator

Source ClinicalTrials.gov

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