Diabetic Peripheral Neuropathy
Conditions
Keywords
vagus nerve stimulation, cognitive functions
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.
Interventions
OTHERA 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.
DEVICEVagus 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.
Sponsors
heba ahmed khalifa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attention/ concentration score | at baseline | Rehacom will be used to assess score of attention/ concentration domain of cognitive function |
| working memory score | at baseline | Rehacom will be used to assess score of working memory domain of cognitive function |
| Executive function score | at baseline | Rehacom will be used to assess score of executive function 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 |
Countries
Egypt
Outcome results
None listed