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

Not Applicable

Active, not recruiting

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Other: A computer based cognitive rehabilitation program (Rehacom system); Device: Vagus nerve stimulation

• Registration Number: NCT06048653
• Lead Sponsor: heba ahmed khalifa

Brief 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.

Study Timeline

• Study Start: 2022-08-02
• Status Verified: 2023-09
• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-16
• Last Update Submitted: 2023-09-16
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-01
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• patients with diabetic polyneuropathy
• Female patients.
• age ranges from 40 to 55 years old.
• Duration of diabetic illness started since at least three years.
• Patients with mild to moderate neuropathy according to Toronto clinical neuropathy score
• Patients with cognitive function ranges from 24 - 15 score according to Mini mental state examination
• Patients with HbA1c ranges from seven to nine score.
• Ambulant patients with or without walking aids.
• Medically and psychologically stable patients without cardiac problems, confirmed by Electro Cardiogram (ECG).
• able to understand instructions.

Exclusion Criteria

• Type I diabetes mellitus.
• Severe visual, verbal or acoustic impairments.
• Sever cognitive dysfunctions or that caused by other cause rather than diabetes mellitus.
• Polyneuropathy caused by other cause rather than diabetes mellitus.
• Other neurological problem as stroke.
• Cardiovascular problems.
• Metallic implants
• Illiterate patients.
• Uncooperative patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Vagus nerve stimulation	The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.
control group	A computer based cognitive rehabilitation program (Rehacom system)	The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system)
study group	A computer based cognitive rehabilitation program (Rehacom system)	The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.

Primary Outcome Measures

Name	Time	Method
Attention/ concentration score	post intervention (after one month)	Rehacom will be used to assess score of attention/ concentration domain of cognitive function
Executive function score	at baseline	Rehacom will be used to assess score of executive function domain of cognitive function
working memory score	post intervention (after one month)	Rehacom will be used to assess score of working memory domain of cognitive function
Executive function	post intervention (after one month)	Rehacom will be used to assess score of executive function domain of cognitive function

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt