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

September 16, 2023 updated by: heba ahmed khalifa
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11432
        • Faculty of physical therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

heba ahmed khalifa

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

September 16, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Peripheral Neuropathy

Clinical Trials on A computer based cognitive rehabilitation program (Rehacom system)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe