Back to resultsEffect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
A computer based cognitive rehabilitation program (Rehacom system)
Vagus nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring vagus nerve stimulation, cognitive functions
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.
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
control group
study group
Arm Description
The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system)
The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.
Outcomes
Primary Outcome Measures
Attention/ concentration score
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
Attention/ concentration score
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
working memory score
Rehacom will be used to assess score of working memory domain of cognitive function
working memory score
Rehacom will be used to assess score of working memory domain of cognitive function
Executive function score
Rehacom will be used to assess score of executive function domain of cognitive function
Executive function
Rehacom will be used to assess score of executive function domain of cognitive function
Secondary Outcome Measures
Full Information
NCT ID
NCT06048653
First Posted
September 16, 2023
Last Updated
September 16, 2023
Sponsor
heba ahmed khalifa
1. Study Identification
Unique Protocol Identification Number
NCT06048653
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
heba ahmed khalifa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
vagus nerve stimulation, cognitive functions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Experimental
Arm Description
The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system)
Arm Title
study group
Arm Type
Experimental
Arm Description
The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.
Intervention Type
Other
Intervention Name(s)
A computer based cognitive rehabilitation program (Rehacom system)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Vagus nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attention/ concentration score
Description
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
Time Frame
at baseline
Title
Attention/ concentration score
Description
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
Time Frame
post intervention (after one month)
Title
working memory score
Description
Rehacom will be used to assess score of working memory domain of cognitive function
Time Frame
at baseline
Title
working memory score
Description
Rehacom will be used to assess score of working memory domain of cognitive function
Time Frame
post intervention (after one month)
Title
Executive function score
Description
Rehacom will be used to assess score of executive function domain of cognitive function
Time Frame
at baseline
Title
Executive function
Description
Rehacom will be used to assess score of executive function domain of cognitive function
Time Frame
post intervention (after one month)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Diabetic polyneuropathy female patients
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshera Darwish, Prof. Dr
Organizational Affiliation
Professor of Physical therapy for Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15590460
Citation
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.
Results Reference
background
PubMed Identifier
31790720
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.
Results Reference
background
Learn more about this trial
Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
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