Effect of Non-invasive Vagus Nerve Stimulation on Cerebrovascular Reactivity and Cognition in Chronic Stroke Patients
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ahmed Kamal
- Telefonnummer: 01110053571
- E-Mail: kamsafahm567@gmaol.com
Studieren Sie die Kontaktsicherung
- Name: Marwa Abd El-Moneim, PHD
- Telefonnummer: 01005661591
- E-Mail: marwa.mostafa@cu.edu.eg
Studienorte
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Cairo, Ägypten
- Ahmed Safwat Kamal
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: True trans-auricular vagus nerve stimulation group
Patients will receive true trans-auricular vagus nerve stimulation and computer based cognitive rehabilitation training (CBCR; RehaCom), in addition to conventional physical therapy program.
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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).
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.
Each cognitive training session will last 30 minutes, with 15 minutes dedicated to each targeted domain. |
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Aktiver Komparator: Sham trans-auricular vagus nerve stimulation group
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.
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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.
Each cognitive training session will last 30 minutes, with 15 minutes dedicated to each targeted domain.
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).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Breathing holding index
Zeitfenster: 4 weeks
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Montreal Cognitive Assessment Scale (MOCA):
Zeitfenster: 4 weeks
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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.
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4 weeks
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Attention/concentration domain (AC)
Zeitfenster: 4 weeks
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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 |
4 weeks
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Figural memory domain
Zeitfenster: 4 weeks
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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 |
4 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Mohamed Soliman, Professor, Cairo University
- Studienleiter: Shimaa Mohamed, Professor, Cairo University
- Studienstuhl: Moshera Darwish, Professor, Cairo University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P.T.REC/012/006121
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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