NCT06048653

Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: heba ahmed khalifa · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Diabetic peripheral neuropathy (DPN) occurs due to long standing hyperglycemia and associated metabolic derangements. Cognitive impairment is a common complication in diabetes mellitus. It is associated with a faster rate of cognitive decline.

Detailed description

This research aims to * determine the effect of non-invasive Vagus nerve stimulation on cognitive functions in diabetic peripheral neuropathy. * investigate the correlation between cognitive function and severity of diabetic neuropathy. * investigate the correlation between cognitive function and quality of life in diabetic peripheral neuropathy.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	A computer based cognitive rehabilitation program (Rehacom system)	Rehacom cognitive rehabilitation software will be used to treat the cognitive dysfunction * Patients will receive training for four weeks, two sessions per week. * Each patient will assume a comfortable sitting position on a chair in front of the screen. * A report will be generated at the end of the session. It will be used for follow up. * Session duration will range from 45 to 60 min. including rest period.
DEVICE	Vagus nerve stimulation	stimulation will be applied on cymba conchae of left external ear. A stimulation of frequency of 20 Hz, pulse width of 200 - 300 Ms and intensity of 0.5 mA. The stimulation will be on for 30 s and off for 48 s.The stimulus duration will range from 20 to 40 min.

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-01-01
• Completion: 2024-02-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Egypt