Effect of Non-invasive Vagus Nerve Stimulation on Cerebrovascular Reactivity and Cognition in Chronic Stroke Patients

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

Conditions

• Stroke

Interventions

DEVICE

Trans-auricular vagus nerve stimulation

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).

DEVICE

Sham trans-auricular vagus nerve stimulation

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).

OTHER

Conventional physical therapy

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.

DEVICE

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.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Mohamed Soliman, Professor · Cairo University

• Shimaa Mohamed, Professor · Cairo University

• Moshera Darwish, Professor · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-02-15

Completion

2027-02-28

Countries

• Egypt

Study Locations