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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Other: A computer based cognitive rehabilitation program (Rehacom system) Device: Vagus nerve stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
Actual Study Start Date : August 2, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Attention/ concentration score [ Time Frame: at baseline ]
    Rehacom will be used to assess score of attention/ concentration domain of cognitive function

  2. Attention/ concentration score [ Time Frame: post intervention (after one month) ]
    Rehacom will be used to assess score of attention/ concentration domain of cognitive function

  3. working memory score [ Time Frame: at baseline ]
    Rehacom will be used to assess score of working memory domain of cognitive function

  4. working memory score [ Time Frame: post intervention (after one month) ]
    Rehacom will be used to assess score of working memory domain of cognitive function

  5. Executive function score [ Time Frame: at baseline ]
    Rehacom will be used to assess score of executive function domain of cognitive function

  6. Executive function [ Time Frame: post intervention (after one month) ]
    Rehacom will be used to assess score of executive function domain of cognitive function


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Diabetic polyneuropathy female patients
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048653


Locations
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Egypt
Faculty of Physical Therapy
Giza, Egypt, 11432
Sponsors and Collaborators
heba ahmed khalifa
Investigators
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Principal Investigator: Moshera Darwish, Prof. Dr Professor of Physical therapy for Neurology
More Information
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Publications:

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Responsible Party: heba ahmed khalifa, Ass. Prof. Dr of Physical therapy for Neurology, Cairo University
ClinicalTrials.gov Identifier: NCT06048653    
Other Study ID Numbers: P.T.REC/012/003942
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by heba ahmed khalifa, Cairo University:
vagus nerve stimulation
cognitive functions
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Polyneuropathies
Diabetic Neuropathies
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases