Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2022
CompletedFirst Submitted
Initial submission to the registry
September 16, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedSeptember 21, 2023
September 1, 2023
1.4 years
September 16, 2023
September 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Attention/ concentration score
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
at baseline
Attention/ concentration score
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
post intervention (after one month)
working memory score
Rehacom will be used to assess score of working memory domain of cognitive function
at baseline
working memory score
Rehacom will be used to assess score of working memory domain of cognitive function
post intervention (after one month)
Executive function score
Rehacom will be used to assess score of executive function domain of cognitive function
at baseline
Executive function
Rehacom will be used to assess score of executive function domain of cognitive function
post intervention (after one month)
Study Arms (2)
control group
EXPERIMENTALThe control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system)
study group
EXPERIMENTALThe study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Physical Therapy
Giza, 11432, Egypt
Related Publications (3)
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.
PMID: 15590460BACKGROUNDBroncel 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.
PMID: 31790720BACKGROUNDDarwish MH, El-Tamawy MS, Alhirsan SM, El-Anany M, Khalifa HA. Effect of Trans-Auricular Vagal Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients. Physiother Res Int. 2025 Apr;30(2):e70063. doi: 10.1002/pri.70063.
PMID: 40285458DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moshera Darwish, Prof. Dr
Professor of Physical therapy for Neurology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ass. Prof. Dr of Physical therapy for Neurology
Study Record Dates
First Submitted
September 16, 2023
First Posted
September 21, 2023
Study Start
August 2, 2022
Primary Completion
January 1, 2024
Study Completion
February 1, 2024
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share