Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
NCT ID: NCT06048653
Last Updated: 2023-09-21
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-08-02
2024-02-29
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control group
The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system)
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.
study group
The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
55 Years
FEMALE
No
Sponsors
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heba ahmed khalifa
OTHER
Responsible Party
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heba ahmed khalifa
Ass. Prof. Dr of Physical therapy for Neurology
Principal Investigators
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Moshera Darwish, Prof. Dr
Role: PRINCIPAL_INVESTIGATOR
Professor of Physical therapy for Neurology
Locations
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Faculty of Physical Therapy
Giza, , Egypt
Countries
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References
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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.
Darwish MH, El-Tamawy MS, Alhirsan SM, El-Anany M, Khalifa HA. Effect of Trans-Auricular Vagal Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients. Physiother Res Int. 2025 Apr;30(2):e70063. doi: 10.1002/pri.70063.
Other Identifiers
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P.T.REC/012/003942
Identifier Type: -
Identifier Source: org_study_id
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