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

• ClinicalTrials.gov Identifier: NCT06048653
• Recruitment Status: Active, not recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: heba ahmed khalifa
• Information provided by (Responsible Party): heba ahmed khalifa, Cairo University

Tracking Information

• First Submitted Date: September 16, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: September 21, 2023
• Actual Study Start Date: August 2, 2022
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2023)

• Attention/ concentration score [ Time Frame: at baseline ]
  Rehacom will be used to assess score of attention/ concentration domain of cognitive function
• Attention/ concentration score [ Time Frame: post intervention (after one month) ]
  Rehacom will be used to assess score of attention/ concentration domain of cognitive function
• working memory score [ Time Frame: at baseline ]
  Rehacom will be used to assess score of working memory domain of cognitive function
• working memory score [ Time Frame: post intervention (after one month) ]
  Rehacom will be used to assess score of working memory domain of cognitive function
• Executive function score [ Time Frame: at baseline ]
  Rehacom will be used to assess score of executive function domain of cognitive function
• Executive function [ Time Frame: post intervention (after one month) ]
  Rehacom will be used to assess score of executive function domain of cognitive function

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Participant)
Primary Purpose: Treatment

• Condition: Diabetic Peripheral Neuropathy

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.

Study Arms

• Experimental: control group
  The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system)
  Intervention: Other: A computer based cognitive rehabilitation program (Rehacom system)
• Experimental: study group
  The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.
  Interventions:

  • Other: A computer based cognitive rehabilitation program (Rehacom system)
  • Device: Vagus nerve stimulation

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 16, 2023): 40
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: February 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Diabetic polyneuropathy female patients

• Ages: 40 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT06048653
• Other Study ID Numbers: P.T.REC/012/003942
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: heba ahmed khalifa, Cairo University
• Original Responsible Party: Same as current
• Current Study Sponsor: heba ahmed khalifa
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Moshera Darwish, Prof. Dr; Professor of Physical therapy for Neurology

• PRS Account: Cairo University
• Verification Date: September 2023