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

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06048653
• Other study ID #: P.T.REC/012/003942
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: February 2024

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
heba ahmed khalifa

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention/ concentration score	Rehacom will be used to assess score of attention/ concentration domain of cognitive function	at baseline
Primary	Attention/ concentration score	Rehacom will be used to assess score of attention/ concentration domain of cognitive function	post intervention (after one month)
Primary	working memory score	Rehacom will be used to assess score of working memory domain of cognitive function	at baseline
Primary	working memory score	Rehacom will be used to assess score of working memory domain of cognitive function	post intervention (after one month)
Primary	Executive function score	Rehacom will be used to assess score of executive function domain of cognitive function	at baseline
Primary	Executive function	Rehacom will be used to assess score of executive function domain of cognitive function	post intervention (after one month)