Clinical trial NCT06048653: Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
Official title: Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: vagus nerve stimulation
cognitive functions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attention/ concentration score
timeFrame: at baseline
measure: Attention/ concentration score
timeFrame: post intervention (after one month)
measure: working memory score
timeFrame: at baseline
measure: working memory score
timeFrame: post intervention (after one month)
measure: Executive function score
timeFrame: at baseline
measure: Executive function
timeFrame: post intervention (after one month)
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Professor of Physical therapy for Neurology
name: Moshera Darwish, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.