Diabetic Peripheral NeuropathyNCT06048653
Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
A study testing A computer based cognitive rehabilitation program (Rehacom system) and Vagus nerve stimulation in people with Diabetic Peripheral Neuropathy, run by heba ahmed khalifa at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- A computer based cognitive rehabilitation program (Rehacom system) and Vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- Metallic implants
- Illiterate patients.
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- A computer based cognitive rehabilitation program (Rehacom system), Vagus nerve stimulation
- Keywords
- vagus nerve stimulation, cognitive functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A computer based cognitive rehabilitation program (Rehacom system)Other
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.
Vagus nerve stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| control group | Experimental | The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system) Receives: Other: A computer based cognitive rehabilitation program (Rehacom system) |
| study group | Experimental | The study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation. Receives: Other: A computer based cognitive rehabilitation program (Rehacom system); Device: Vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention/ concentration score
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
Measured: at baseline
Attention/ concentration score
Rehacom will be used to assess score of attention/ concentration domain of cognitive function
Measured: post intervention (after one month)
working memory score
Rehacom will be used to assess score of working memory domain of cognitive function
Measured: at baseline
working memory score
Rehacom will be used to assess score of working memory domain of cognitive function
Measured: post intervention (after one month)
Executive function score
Rehacom will be used to assess score of executive function domain of cognitive function
Measured: at baseline
Executive function
Rehacom will be used to assess score of executive function domain of cognitive function
Measured: post intervention (after one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Aug 2022
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- heba ahmed khalifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, heba ahmed khalifa, Cairo University
- Investigators
- Moshera Darwish, Prof. Dr, Principal investigator, Professor of Physical therapy for Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048653
- Sponsor's protocol ID
- P.T.REC/012/003942
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15590460Broncel 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.
PubMed 31790720Darwish 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.
PubMed 40285458
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients
- ClinicalTrials.gov ID
- NCT06048653
- Acronym / sponsor ID
- P.T.REC/012/003942
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- vagus nerve stimulation, cognitive functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- heba ahmed khalifaUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: A computer based cognitive rehabilitation program (Rehacom system)The control group (GI) will receive a computer based cognitive rehabilitation program (Rehacom system) |
| study group | Experimental | Other: A computer based cognitive rehabilitation program (Rehacom system), Device: Vagus nerve stimulationThe study group (GII) will receive a computer based cognitive rehabilitation program (Rehacom system) in addition to Vagus nerve stimulation. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | control group, study group |
| Vagus nerve stimulationstimulation 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. | Device | study group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 15590460Awad 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.
- Background: PubMed 31790720Broncel 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.
- Derived from this study: PubMed 40285458Darwish 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshera Darwish, Prof. Dr principal investigator
Professor of Physical therapy for Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A computer based cognitive rehabilitation program (Rehacom system) and Vagus nerve stimulation in people with Diabetic Peripheral Neuropathy, run by heba ahmed khalifa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention/ concentration score (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048653, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.