StrokeNCT07626242
Effect of Non-invasive Vagus Nerve Stimulation on Cerebrovascular Reactivity and Cognition in Chronic Stroke Patients
A study testing Trans-auricular vagus nerve stimulation, Conventional physical therapy and Computer based cognitive rehabilitation training in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to assess the effect of non-invasive vagus nerve stimulation on cerebrovascular reactivity and cognition in chronic stroke patients Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Trans-auricular vagus nerve stimulation, Conventional physical therapy and Computer based cognitive rehabilitation training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty chronic ischemic hemiparetic patients, of both sexes, will represent the sample.
- The patient's age will range from 50 to 60 years old.
- Duration of illness will range from six months to twelve months.
- Patients with mild cognitive impairment according to Montreal Cognitive Assessment (MoCA) scale (from 18 to 25).
- Spasticity will be 1 or 1+ according to Modified Aschworth scale.
- Educated patients.
Who cannot join
- The patients will be excluded if they have one of the followings:
- Patients with other neurological disease that affect cognition.
- Visual, verbal or hearing impairments that can interfere with communication.
- Depression assessed by Hamilton Depression Scale (Ham-D).
- Patients with poor bone window.
- History of psychiatric disease.
Show all 12Show fewer
- Hemorrhagic stroke patients.
- Uncontrolled blood pressure or low heart rate.
- Uncontrolled diabetes (>130 mg/dL especially if consistently over 150 to 160 mg/dL)
- Patients with any taVNS contraindications (open heart surgery, pacemaker or other implants, previous surgical intervention on Vagus nerve, Facial or ear pain, and recent ear trauma)
- Stroke patients with severe cognitive impairment.
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to assess the effect of non-invasive vagus nerve stimulation on cerebrovascular reactivity and cognition in chronic stroke patients
Read the detailed description
Stroke is a leading cause of disability worldwide, resulting in physical, cognitive, and emotional impairments. These impairments significantly affect individuals, families, and communities. It imposes a substantial social and financial burden on healthcare systems and economies. Deficits in cognitive functions are highly associated with reduced treatment outcomes after stroke. This interferes with social and occupational recovery and limit psychosocial functioning.
Introducing new therapeutic methods such as non-invasive vagus nerve stimulation (VNS) alongside traditional rehabilitation is essential for enhancing cognitive function after stroke. Vagus nerve stimulation can be invasive or non-invasive. Non-invasive method of VNS via transcutaneous stimulation of the peripheral auricular branch of the Vagus nerve (taVNS) is safer, better-tolerated method for delivering VNS with the same effect of invasive VNS.
There are few key human studies that assessed the effects of transcutaneous vagus nerve stimulation (tVNS) on cerebrovascular reactivity (CVR) and cognition in chronic stroke patients. Up to our knowledge, this is the first Egyptian study that will assess the effect of transcutaneous vagus nerve stimulation on cerebrovascular reactivity and cognition in chronic stroke patients. This study will hopefully be of benefit in the physical therapy field. This may guide rehabilitation programs of physical therapy toward better results.
- Conditions
- Stroke
- Being tested
- Trans-auricular vagus nerve stimulation, Sham trans-auricular vagus nerve stimulation, Conventional physical therapy, Computer based cognitive rehabilitation training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-auricular vagus nerve stimulationDevice
Transcutaneous vagal nerve stimulation will be done through EME Therapic 9200 electrotherapy device (EME Physio, Via degli Abeti 88/161122 Pesaro (PU), Italy). A clip electrode will be applied on cymba conchae of left ear. Stimulation parameters will be set to 30 minutes treatment time, a pulse width of 300 microseconds, pulse frequency 30 HZ and a pulsed mode with a duty cycle of 50% (30 sec on and 30 sec off time).
Sham trans-auricular vagus nerve stimulationDevice
Patients will receive false trans-auricular vagus nerve stimulation through EME Therapic 9200 electrotherapy device (EME Physio, Via degli Abeti 88/161122 Pesaro (PU), Italy). The ear clip electrode will be attached to the center of the left earlobe of the patient, as it is free from vagus innervation. Stimulation parameters will be set to 30 minutes treatment time, a pulse width of 300 microseconds, pulse frequency 30 HZ and a pulsed mode with a duty cycle of 50% (30 sec on and 30 sec off time).
Conventional physical therapyOther
The physical therapy program will include strengthening exercises to the antispastic muscles, stretching exercises to spastic muscles, gait training exercises, proprioceptive neuromuscular facilitation exercises for upper limb and lower limb, and graduated balance exercise.
Computer based cognitive rehabilitation trainingDevice
- RehaCom (Dr. G. Schuhfrted Ges.m.b.II., model No. A-2340 device) will be used in this study for assessment and training two cognitive domains: attention/concentration and figural memory. Each patient will be in a comfortable sitting position in front of a screen during the session. The two domains will be assessed at the end of each session.
- Attention/concentration domain (AC) includes 24 levels of difficulty. Assessment will start at level one and will be advanced to more challenging levels.
- Figural memory domain includes nine levels of difficulty. Assessment will start at level one and will be advanced to more challenging levels.
Each cognitive training session will last 30 minutes, with 15 minutes dedicated to each targeted domain.
| Study group | Role | What they receive |
|---|---|---|
| True trans-auricular vagus nerve stimulation group | Experimental | Patients will receive true trans-auricular vagus nerve stimulation and computer based cognitive rehabilitation training (CBCR; RehaCom), in addition to conventional physical therapy program. Receives: Device: Trans-auricular vagus nerve stimulation; Other: Conventional physical therapy; Device: Computer based cognitive rehabilitation training |
| Sham trans-auricular vagus nerve stimulation group | Active comparator | Patients will receive sham trans-auricular vagus nerve stimulation (ta-VNS), and computer based cognitive rehabilitation training (CBCR; RehaCom) in addition to conventional physical therapy program. Receives: Device: Sham trans-auricular vagus nerve stimulation; Other: Conventional physical therapy; Device: Computer based cognitive rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing holding index
Transcranial doppler ultrasonography technique will be used to assess cerebrovascular reactivity by measuring the percentage increase in cerebral blood flow velocity during apnea, divided by the duration of breath hold in seconds.
Breath holding index will be calculated according to the following equation: BHI= ((Mean Flow Velocity (MFV) post- Mean Flow Velocity (MFV)rest/ Mean Flow Velocity (MFV)rest) × (100/Duration in second)) normal range:1.03-1.65.
Measured: 4 weeks
Secondary outcomes (3)
Montreal Cognitive Assessment Scale (MOCA):
It will be used to assess cognition before and after treatment period for all patients. Each patient will be asked to write and draw using the non-affected hand. The test consists of a single page, with reading items presented in a clear and appropriately sized font. The assessment will include short-term memory, executive functions, visuospatial abilities, language, attention, concentration, working memory, and temporal and spatial orientation. Total score of MoCA is from 0 to 30. From 26-30 is normal cognition, from 18-25 is mild cognitive impairment (MCI), from 10-17 is moderate cognitive impairment, and less than ten is Severe cognitive impairment.
Measured: 4 weeks
Attention/concentration domain (AC)
RehaCom (Dr. G. Schuhfrted Ges.m.b.II., model No. A-2340 device) will be used in this study to assess and rehabilitate the cognitive function in stroke patients. It is a valid and reliable instrument for assessing and improving cognitive functions in stroke patients. Attention/concentration domain (AC) includes 24 levels of difficulty. Assessment will start at level one and will be advanced to more challenging levels.
normal range :10-12 level; indicative cognitive impairment: below 10 level
Measured: 4 weeks
Figural memory domain
RehaCom (Dr. G. Schuhfrted Ges.m.b.II., model No. A-2340 device) will be used in this study to assess and rehabilitate the cognitive function in stroke patients. It is a valid and reliable instrument for assessing and improving cognitive functions in stroke patients. Figural memory domain includes 9 levels of difficulty. Assessment will start at level one and will be advanced to more challenging levels.
normal range :7-8 level; indicative cognitive impairment: below 7 level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startJun 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Safwat Kamal, Cairo University
- Investigators
- Mohamed Soliman, Professor, Study director, Cairo UniversityShimaa Mohamed, Professor, Study director, Cairo UniversityMoshera Darwish, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626242
- Sponsor's protocol ID
- P.T.REC/012/006121
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Vagus Nerve Stimulation on Cerebrovascular Reactivity and Cognition in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT07626242
- Acronym / sponsor ID
- P.T.REC/012/006121
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
This study will be conducted to assess the effect of non-invasive vagus nerve stimulation on cerebrovascular reactivity and cognition in chronic stroke patients
Detailed description
Stroke is a leading cause of disability worldwide, resulting in physical, cognitive, and emotional impairments. These impairments significantly affect individuals, families, and communities. It imposes a substantial social and financial burden on healthcare systems and economies. Deficits in cognitive functions are highly associated with reduced treatment outcomes after stroke. This interferes with social and occupational recovery and limit psychosocial functioning.
Introducing new therapeutic methods such as non-invasive vagus nerve stimulation (VNS) alongside traditional rehabilitation is essential for enhancing cognitive function after stroke. Vagus nerve stimulation can be invasive or non-invasive. Non-invasive method of VNS via transcutaneous stimulation of the peripheral auricular branch of the Vagus nerve (taVNS) is safer, better-tolerated method for delivering VNS with the same effect of invasive VNS.
There are few key human studies that assessed the effects of transcutaneous vagus nerve stimulation (tVNS) on cerebrovascular reactivity (CVR) and cognition in chronic stroke patients. Up to our knowledge, this is the first Egyptian study that will assess the effect of transcutaneous vagus nerve stimulation on cerebrovascular reactivity and cognition in chronic stroke patients. This study will hopefully be of benefit in the physical therapy field. This may guide rehabilitation programs of physical therapy toward better results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True trans-auricular vagus nerve stimulation group | Experimental | Device: Trans-auricular vagus nerve stimulation, Other: Conventional physical therapy, Device: Computer based cognitive rehabilitation trainingPatients will receive true trans-auricular vagus nerve stimulation and computer based cognitive rehabilitation training (CBCR; RehaCom), in addition to conventional physical therapy program. |
| Sham trans-auricular vagus nerve stimulation group | Active comparator | Device: Sham trans-auricular vagus nerve stimulation, Other: Conventional physical therapy, Device: Computer based cognitive rehabilitation trainingPatients will receive sham trans-auricular vagus nerve stimulation (ta-VNS), and computer based cognitive rehabilitation training (CBCR; RehaCom) in addition to conventional physical therapy program. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Forty chronic ischemic hemiparetic patients, of both sexes, will represent the sample.
- The patient's age will range from 50 to 60 years old.
- Duration of illness will range from six months to twelve months.
- Patients with mild cognitive impairment according to Montreal Cognitive Assessment (MoCA) scale (from 18 to 25).
- Spasticity will be 1 or 1+ according to Modified Aschworth scale.
Key exclusion criteria (12 listed)
- The patients will be excluded if they have one of the followings:
- Patients with other neurological disease that affect cognition.
- Visual, verbal or hearing impairments that can interfere with communication.
- Depression assessed by Hamilton Depression Scale (Ham-D).
- Patients with poor bone window.
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 |
|---|---|---|
| Trans-auricular vagus nerve stimulationTranscutaneous vagal nerve stimulation will be done through EME Therapic 9200 electrotherapy device (EME Physio, Via degli Abeti 88/161122 Pesaro (PU), Italy). A clip electrode will be applied on cymba conchae of left ear. Stimulation parameters will be set to 30 minutes treatment time, a pulse width of 300 microseconds, pulse frequency 30 HZ and a pulsed mode with a duty cycle of 50% (30 sec on and 30 sec off time). | Device | True trans-auricular vagus nerve stimulation group |
| Sham trans-auricular vagus nerve stimulationPatients will receive false trans-auricular vagus nerve stimulation through EME Therapic 9200 electrotherapy device (EME Physio, Via degli Abeti 88/161122 Pesaro (PU), Italy). The ear clip electrode will be attached to the center of the left earlobe of the patient, as it is free from vagus innervation. Stimulation parameters will be set to 30 minutes treatment time, a pulse width of 300 microseconds, pulse frequency 30 HZ and a pulsed mode with a duty cycle of 50% (30 sec on and 30 sec off time). | Device | Sham trans-auricular vagus nerve stimulation group |
| Conventional physical therapyThe physical therapy program will include strengthening exercises to the antispastic muscles, stretching exercises to spastic muscles, gait training exercises, proprioceptive neuromuscular facilitation exercises for upper limb and lower limb, and graduated balance exercise. | Other | Sham trans-auricular vagus nerve stimulation group, True trans-auricular vagus nerve stimulation group |
| Computer based cognitive rehabilitation training* RehaCom (Dr. G. Schuhfrted Ges.m.b.II., model No. A-2340 device) will be used in this study for assessment and training two cognitive domains: attention/concentration and figural memory. Each patient will be in a comfortable sitting position in front of a screen during the session. The two domains will be assessed at the end of each session. * Attention/concentration domain (AC) includes 24 levels of difficulty. Assessment will start at level one and will be advanced to more challenging levels. * Figural memory domain includes nine levels of difficulty. Assessment will start at level one and will be advanced to more challenging levels. Each cognitive training session will last 30 minutes, with 15 minutes dedicated to each targeted domain. | Device | Sham trans-auricular vagus nerve stimulation group, True trans-auricular vagus nerve stimulation group |
Primary outcome
Breathing holding index
Time frame: 4 weeks
Transcranial doppler ultrasonography technique will be used to assess cerebrovascular reactivity by measuring the percentage increase in cerebral blood flow velocity during apnea, divided by the duration of breath hold in seconds. Breath holding index will be calculated according to the following equation: BHI= ((Mean Flow Velocity (MFV) post- Mean Flow Velocity (MFV)rest/ Mean Flow Velocity (MFV)rest) × (100/Duration in second)) normal range:1.03-1.65.
3 secondary outcomes
Montreal Cognitive Assessment Scale (MOCA):
Time frame: 4 weeks
Attention/concentration domain (AC)
Time frame: 4 weeks
Figural memory domain
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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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.
Mohamed Soliman, Professor study director
Cairo University
Shimaa Mohamed, Professor study director
Cairo University
Moshera Darwish, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-auricular vagus nerve stimulation, Conventional physical therapy and Computer based cognitive rehabilitation training in people with Stroke, run by Cairo University 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Kamal (01110053571, kamsafahm567@gmaol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing holding index (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.