Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome
Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome
1 other identifier
interventional
70
1 country
1
Brief Summary
Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Vagus nerve stimulation group(VNS) Patients rested on their sides in a sitting position. Following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. The training regimen included ten different forms of resistance and aerobic exercises.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedAugust 14, 2024
August 1, 2024
2 months
March 14, 2023
August 10, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Emotional eating
Emotional Eating was measured by a 15-item version of the Emotional Eating Scale. The scale required responses from 0 (no desire to eat) to 4 (an overwhelming urge to eat) based on "… the extent which the following feelings presently lead you to feel an urge to eat. A lower score indicated less of an urge to eat when the designated emotional state was present.
4 weeks
Patient satisfaction measures
The Short Assessment of Patient Satisfaction (SAPS) is a seven-item scale that can be utilized to measure patient satisfaction with their treatment. The seven-item Short Assessment of Patient Satisfaction (SAPS), which is scored on a 5-point scale (0-4) SAPS has a continuous score range of 0 to 28. SAPS categorical responses include 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied.
4 weeks
Cortisol level
Participants use a disposable plastic straw to 'drool' saliva into the tube after collecting it in their mouths for a predetermined period of time (one minute) Saliva samples for cortisol measurement kept at room temperature until they are examined in a lab (4 to 6 hours)
4 weeks
Secondary Outcomes (1)
Body weight
4 weeks
Study Arms (2)
Vagus nerve stimulation group
EXPERIMENTALVagus nerve stimulation group
Circuit weight training group Group
EXPERIMENTALCircuit weight training group Group
Interventions
ear clips were placed in the ear region (auricular concha) at the stimulation site. The following stimulation settings were used: 1) density wave set to 20 Hz with a wave width of less than 1 ms; 2) intensity tuned to the patient's tolerance (4-6 mA)
The training regimen included ten different forms of resistance and aerobic exercise that were done three times a week for four weeks. The resistance training program included push-ups, squats, crunches, lunges, and a superman exercise program that included light jumping, jogging on the spot, foot stomping, steps, and jumping jacks
Eligibility Criteria
You may qualify if:
- having two or more than one of the following:
- Type 2 diabetes Miletus
- Hypertensive.
- Abnormal Cholesterol or Triglyceride level.
- BMI more than 30 kg/m
- Waist circumference more than 94 cm.
You may not qualify if:
- Vagotomy.
- Diathermy.
- Wallowing difficulties.
- Dyspnea.
- Cardiac arrhythmia.
- Seizure.
- Previous brain injury or surgery.
- Dysautonomia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rana Elbannalead
Study Sites (1)
Outpatient clinic faculty of physical therapy at Cairo University
Giza, 12613, Egypt
Related Publications (1)
Elbanna RHM, Elabd SOA, Saleh MSM, Alghitany SIA. Effect of adding noninvasive auricular Vagal nerve stimulation to exercise program on emotional eating and stress responsiveness in patient with metabolic syndrome. Disabil Rehabil. 2025 Dec;47(24):6367-6374. doi: 10.1080/09638288.2025.2506824. Epub 2025 May 17.
PMID: 40382680DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- lecturer at faculty of physical therapy at Cairo University
Study Record Dates
First Submitted
March 14, 2023
First Posted
March 27, 2023
Study Start
March 1, 2023
Primary Completion
April 30, 2023
Study Completion
May 30, 2023
Last Updated
August 14, 2024
Record last verified: 2024-08