Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This research aims to
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determine the effect of non-invasive Vagus nerve stimulation on cognitive functions in diabetic peripheral neuropathy.
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investigate the correlation between cognitive function and severity of diabetic neuropathy.
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investigate the correlation between cognitive function and quality of life in diabetic peripheral neuropathy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: control group The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system) |
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.
|
| Experimental: study group 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)
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.
|
Outcome Measures
Primary Outcome Measures
- Attention/ concentration score [at baseline]
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
- Attention/ concentration score [post intervention (after one month)]
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
- working memory score [post intervention (after one month)]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients with diabetic polyneuropathy
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Female patients.
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age ranges from 40 to 55 years old.
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Duration of diabetic illness started since at least three years.
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Patients with mild to moderate neuropathy according to Toronto clinical neuropathy score
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Patients with cognitive function ranges from 24 - 15 score according to Mini mental state examination
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Patients with HbA1c ranges from seven to nine score.
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Ambulant patients with or without walking aids.
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Medically and psychologically stable patients without cardiac problems, confirmed by Electro Cardiogram (ECG).
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able to understand instructions.
Exclusion Criteria:
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Type I diabetes mellitus.
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Severe visual, verbal or acoustic impairments.
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Sever cognitive dysfunctions or that caused by other cause rather than diabetes mellitus.
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Polyneuropathy caused by other cause rather than diabetes mellitus.
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Other neurological problem as stroke.
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Cardiovascular problems.
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Metallic implants
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Illiterate patients.
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Uncooperative patients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Physical Therapy | Giza | Egypt | 11432 |
Sponsors and Collaborators
- heba ahmed khalifa
Investigators
- Principal Investigator: Moshera Darwish, Prof. Dr, Professor of Physical therapy for Neurology
Study Documents (Full-Text)
None provided.More Information
Publications
- Awad N, Gagnon M, Messier C. The relationship between impaired glucose tolerance, type 2 diabetes, and cognitive function. J Clin Exp Neuropsychol. 2004 Nov;26(8):1044-80. doi: 10.1080/13803390490514875.
- Broncel A, Bocian R, Klos-Wojtczak P, Kulbat-Warycha K, Konopacki J. Vagal nerve stimulation as a promising tool in the improvement of cognitive disorders. Brain Res Bull. 2020 Feb;155:37-47. doi: 10.1016/j.brainresbull.2019.11.011. Epub 2019 Nov 29.
- P.T.REC/012/003942