NCT07626242

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
9mo left

Started Jun 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress5%
Jun 2026Feb 2027

First Submitted

Initial submission to the registry

May 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 31, 2026

Last Update Submit

May 31, 2026

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (3)

  • Montreal Cognitive Assessment Scale (MOCA):

    4 weeks

  • Attention/concentration domain (AC)

    4 weeks

  • Figural memory domain

    4 weeks

Study Arms (2)

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.

Device: Trans-auricular vagus nerve stimulationOther: Conventional physical therapyDevice: 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.

Device: Sham trans-auricular vagus nerve stimulationOther: Conventional physical therapyDevice: Computer based cognitive rehabilitation training

Interventions

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).

True trans-auricular vagus nerve stimulation group
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).

Sham trans-auricular vagus nerve stimulation group
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.

Sham trans-auricular vagus nerve stimulation groupTrue trans-auricular vagus nerve stimulation group
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.

Sham trans-auricular vagus nerve stimulation groupTrue trans-auricular vagus nerve stimulation group

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Safwat Kamal

Cairo, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mohamed Soliman, Professor

    Cairo University

    STUDY DIRECTOR

  • Shimaa Mohamed, Professor

    Cairo University

    STUDY DIRECTOR

  • Moshera Darwish, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Ahmed Kamal

CONTACT

01110053571kamsafahm567@gmaol.com

Marwa Abd El-Moneim, PHD

CONTACT

01005661591marwa.mostafa@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 31, 2026

First Posted

June 4, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations

EG(1)