Multi-device Testing for Autonomic Nervous System Stimulation

The Vagus nerve (VN) serve as an "unconscious inner brain" that integrates messages from the body and provides metabolic homeostatic regulation to various organs.In this study the investigators want to compare different ways to stimulate the vagus nerve to assess their respective effects compared to a sham stimulation.

Each participant will be exposed in a random way to 7 different ways to stimulate the VN:

• Manual Head Massage
• Mechanical Head Massager (BREO Inc. Helmet)
• Low laser Therapy (LLT)
• Sham LLT
• Transcutaneous Electrical Nervous Stimulation (TENS) ear stimulation (as testing phase prototype device)
• Deep and slow breathing (as testing intervention based on video app)
• Relaxed reading time (as control situation)

Therefore, within the same design the investigators want to conduct two separate studies that should lead to two separate publications:

• Study 1: comparison of manual head massage to mechanical Helmet massager and relaxed reading
• Study 2: comparison of LLT with sham LLT and relaxed reading

The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely observational to gain knowledge in context of a convenient design.

Study Overview

• Status: Completed
• Conditions: Vagus Nerve Stimulation
• Intervention / Treatment: Other: Manual Head Massage; Device: BREO Helmet Massager; Device: Low Laser Therapy (LLT); Device: Sham LLT; Device: TENS ear stimulation; Behavioral: Deep and Slow breathing; Behavioral: Relaxed Reading time

Detailed Description

OBJECTIVES Overall objective is to assess the respective effects of the different ways to stimulate the Vagus Nerve on the Heart Rate Variability (HRV) parameters: High Frequency (HF), Low Frequency (LF), Total Power (TP), Heart rate (HR), and blood pressure (BP).

Specific objectives:

• Comparison of Manual Head Massage to Mechanical Head Massager to Control situation
• Comparison of Low Laser Therapy (LLT) to sham LLT to control situation
• Effects of TENS ear stimulation (descriptive)
• Effects of Deep and Slow breathing (descriptive)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers aged 20 to 40 in normal context

Exclusion Criteria:

• To have work night shift the night before
• To use certain drugs that affect the ANS (beta blockers, beta stimulant, hypnotic, for instance)
• To be in situation of unusual life stress
• To have a chronic disease that require some daily treatment
• Not to stay in Beijing for the duration of the investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Head massage by therapist; Head massage therapist will practice massage covering the scalp, front head, occipital area and neck.	Other: Manual Head Massage; Duration 10 minutes.
Active Comparator: Helmet massage BREO; Breo helmet will be installed for massaging the head at different defined places.	Device: BREO Helmet Massager; Duration 10 minutes.
Active Comparator: Low Laser Therapy; Laser light can penetrate the skin and stimulate the nervous connections. The investigators will use a laser pen (Min Sheng).	Device: Low Laser Therapy (LLT); Duration 7 minutes.
Active Comparator: Sham Low Laser Therapy; The investigators will use the same laser pen, but without laser beam.	Device: Sham LLT; Duration 7 minutes.
Active Comparator: TENS ear stimulation; The investigators will use the (Hwato) device that provides electrical pulse at various frequency and intensity. This TENS device is a prototype modified for ear stimulation.	Device: TENS ear stimulation; Duration 7 minutes.
Active Comparator: Deep and Slow breathing; This intervention is guided by an app that leads to a full respiratory.	Behavioral: Deep and Slow breathing; A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.
Sham Comparator: Relaxed Reading time; Participants will read the newspaper in a quiet environment.	Behavioral: Relaxed Reading time; Duration 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of HRV recording parameters	The investigators will use the BIOPAC Machine that captures ECG data, signals were sampled at 500 Hz throughout the testing. Recorded data were reviewed and analyzed using AcqKnowledge software version 4.2. The HRV recording parameters include: (1) Very Low Frequency (VLF) (< 0.04 Hz), (2) Low Frequency (LF) (0.04 - 0.15 Hz), (3) High Frequency (HF) (0.15 to 0.4 Hz), (4) Total Power (TP), which was calculated by summing up all frequency bands, (5) Total Power partial (TPp) (HF + LF), (6) HFnu (normalized unit of HF), (7) Ratio (HF divided by LF).	Changes from baseline HRV parameters at post intervention 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Blood Pressure (Systolic and Diastolic Blood pressure)	Both systolic and diastolic blood pressure will be recorded by an automated monitoring device (OMROM - HEM 7124) at baseline (after the 5 minutes rest) and at the end of the 15 minutes follow-up.	Change from baseline systolic and diastolic blood pressure at post intervention 15 minutes
Change of Heart Rate	Heart rate will be monitored at the same time of blood pressure	Change from baseline heart rate at post intervention 15 minutes
Change of Body Tension	Body tension is assessed using a a 10-point Likert-scale (the minimum score is 0, and the maximum score is 10)ratings of perceived body tension (BT) as indicator of stress. The highers scores indicate more stress.	Change from baseline body tension at post intervention 15 minutes

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Collet Jean-Paul, MD, Phd, Advanced Innovation Center for Human Brain Protection

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): March 24, 2020

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Vagus Nerve Stimulation; Parasympathetic Nervous System; Head Massage; Low Laser therapy
• Other Study ID Numbers: 119209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Need to contact the PI (Dr Collet). Dataset will be transferred with respect of the privacy and confidentiality
• IPD Sharing Time Frame: About one month
• IPD Sharing Access Criteria: Demand from one academic center
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No