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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06048653
Recruitment Status : Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
heba ahmed khalifa, Cairo University

Tracking Information
First Submitted Date  ICMJE September 16, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date  ICMJE August 2, 2022
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Diabetic Peripheral Neuropathy
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 16, 2023)
40
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Diabetic polyneuropathy female patients
Ages  ICMJE 40 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06048653
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party heba ahmed khalifa, Cairo University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE heba ahmed khalifa
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Moshera Darwish, Prof. Dr Professor of Physical therapy for Neurology
PRS Account Cairo University
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP