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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Other: A computer based cognitive rehabilitation program (Rehacom system)
* Device: Vagus nerve stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system); and the study group (GII) will receive the same program as (GI) in addition to Vagus nerve stimulation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system) | Other: A computer based cognitive rehabilitation program (Rehacom system)<br>* 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.<br>|
| Experimental: study group<br>The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation. | Other: A computer based cognitive rehabilitation program (Rehacom system)<br>* 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.<br>Device: Vagus nerve stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention/ concentration score | Rehacom will be used to assess score of attention/ concentration domain of cognitive function | at baseline | 
| Attention/ concentration score | Rehacom will be used to assess score of attention/ concentration domain of cognitive function | post intervention (after one month) | 
| working memory score | Rehacom will be used to assess score of working memory domain of cognitive function | at baseline | 
| working memory score | Rehacom will be used to assess score of working memory domain of cognitive function | post intervention (after one month) | 
| Executive function score | Rehacom will be used to assess score of executive function domain of cognitive function | at baseline | 
| Executive function | Rehacom will be used to assess score of executive function domain of cognitive function | post intervention (after one month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vagus nerve stimulation, cognitive functions