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

heba ahmed khalifa40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Peripheral Neuropathy

Interventions

A computer based cognitive rehabilitation program (Rehacom system)OTHER

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.

Vagus nerve stimulationDEVICE

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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Physical Therapy

Giza, Egypt

Outcomes

Primary Outcomes

Attention/ concentration score

Rehacom will be used to assess score of attention/ concentration domain of cognitive function

Time frame: at baseline

Attention/ concentration score

Rehacom will be used to assess score of attention/ concentration domain of cognitive function

Time frame: post intervention (after one month)

working memory score

Rehacom will be used to assess score of working memory domain of cognitive function

Time frame: at baseline

working memory score

Rehacom will be used to assess score of working memory domain of cognitive function

Time frame: post intervention (after one month)

Executive function score

Rehacom will be used to assess score of executive function domain of cognitive function

Time frame: at baseline

Executive function

Rehacom will be used to assess score of executive function domain of cognitive function

Time frame: post intervention (after one month)

Data from ClinicalTrials.gov

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