[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624083":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Cairo University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous Vagus nerve stimulation","EXPERIMENTAL","Patients will receive the same traditional physical therapy as in traditional physical therapy group in addition to 30 min of transcutaneous auricular vagus nerve stimulation 5 sessions per week for 6 weeks.",[13,14],"Other: Conventional physical therapy program","Device: Transcutaneous auricular vagus nerve stimulation",{"label":16,"type":17,"description":18,"interventionNames":19},"traditional physical therapy","ACTIVE_COMPARATOR","Patients will receive 30 min of traditional physical therapy, and 30 min of placebo Non-Invasive vagus nerve stimulation, 5 sessions per week for 6 weeks",[13,20],"Device: Sham therapy",[22,27,32],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Conventional physical therapy program","Flexibility exercises:\n\nGentle passive progressive stretching and self-stretches for lower limbs selected muscles.\n\nMuscle strengthening (using a variety of modes as appropriate e.g. isometric, graded weight progression, open and close chain) Aerobic activity. Posture and balance training (for falls prevention and stability). Gait (can improve proprioception and gait pattern in patients with diabetic neuropathy",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Sham therapy","A sterile cotton ball will be placed in the ear after sterilizing the cavum conchae and cymba conchae with 75% alcohol. The stimulation electrode will be inserted into the cotton ball, and then the cotton ball will be fixed after ensuring that the stimulator does not touch the skin; the lead wire will be connected. The therapeutic apparatus will be turned on, and the parameters will be the same as those for the transcutaneous vagus nerve stimulation group. All patients will see the lights flashing when the stimulator is running",[16],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Transcutaneous auricular vagus nerve stimulation","The antihelix and cymba concha will be sterilized with 75% alcohol, and then the nerve stimulation electrode (the ear clips) will be attached. The positive pole of the lead will be connected to the antihelix, and the negative pole will be connected to the cymba concha The device parameters include a wave width of 0.2 ms ± 30% and a pulse frequency of 20 Hz. Current intensity will gradually increase to a tolerable level of 4-6 mA, with stimulation lasting for 30 minutes. Heart rates of participants will be monitored continuously, with stimulation ceasing if rates drop below 50 beats per minute. Both the study and control groups will receive the same conventional physical therapy program.",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Hoda Mamdouh nematallah, assisstant lecturer","CONTACT","01096551775","hmamdouh@horus.edu.eg",[43],{"facility":44,"status":45,"city":46,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"outpatient clinic, faculty of physical therapy, Horus university","RECRUITING","Damietta","Egypt","EG",{"type":50,"coordinates":51},"Point",[52,53],31.81332,31.41648,{"lat":53,"lon":52},[56],{"name":57,"role":39,"phone":40,"phoneExt":26,"email":41},"Hoda Mamdouh Nematallah, Assisstant lecturer",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Hoda Mamdouh Nematallah","principal investigator","100624083","effect-of-vagus-nerve-stimulation-on-pain-intensity-nerve-conduction-studies-and-functional-outcomes-in-diabetic-peripheral-neuropathy-patients-100624083",false,"NCT07405021","Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients","Inclusion Criteria\n\n* Thirty patients diagnosed with diabetic neuropathy of both genders.\n* Age range between 45 and 60 years.\n* Presence of numbness and\u002For pain in the feet with no other identifiable cause.\n* Pain characterized as stabbing, electric shock-like, or burning in nature.\n* Presence of glove-stocking sensory changes and abnormal sensations in the distal lower limbs.\n* Ability to ambulate independently without assistance.\n* Patients under full medical control.\n* Hemoglobin A1c levels ranging from 6.5% to 7%.\n* History of diabetes mellitus for more than 5 years.\n\nExclusion Criteria\n\n* Implantation of cardiac pacemakers or other electrical stimulation devices.\n* Presence of sinus bradycardia, sick sinus syndrome, or other cardiac arrhythmias.\n* Lumbar radiculopathy.\n* Psychiatric or mental disorders or history of seizures.\n* Visual or auditory impairments or tremors affecting balance.\n* Presence of other neuromuscular disorders.\n* Foot deformities or active foot ulcers.\n* History of lower limb surgical operations.","ALL","45 Years","60 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","To evaluate the efficacy of vagus nerve stimulation in reducing neuropathic pain, symptom severity, electrophysiological studies and functional outcomes in patients with diabetic peripheral neuropathy.",[79,80],"Transcutaneous Vagal Nerve Stimulation (tVNS)","Diabetic Polyneuropathy","2026-02-09",{"date":83,"type":84},"2026-02-12","ACTUAL",{"date":86,"type":84},"2026-01-01",{"date":88,"type":73},"2026-04-01",{"name":5,"class":6},1]