Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

NCT ID: NCT03899662

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-07-31

Brief Summary

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Neurophysilogical, neuropsychological evaluation and cognitive and physical training

Detailed Description

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24 sessions (8 weeks, 3 times per week) of cognitive and physical training via computer. Each session consisted of 45 minutes of cognitive traing (BrainHQ platform https://www.brainhq.com/) and 45 minutes of physical training (FitForAll platform https://www.fitforall.gr/play/app/). Cognitive training included memory, attention, velocity, intelligence etc. Physical training included aerobic, strength flexibility and other excercises. All evaluations were performed 1-14 before the initiation of the interventions and 1-14 after their completion. Neurophysiological evaluation consisted of EEG with the use of 128 electrode-machine and the protocol included 5 minuted of eyes closed and 5 minutes of eyes open. Neuropsychological evaluation included Trail Making Test (A \& B), Verbal Fluency, Stroop test, Wechsler Memory - Cubes (visuospatial), MoCA, FAB (Screening for frontal damage) and Eyes Test (Theory of Mind). Also, the physical condition evaluation included 6-Minute Walking Distance (6MWD), ΒΜΙ, HandGrip Strength Test, Short Physical Performance Battery Protocol.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Cognitive and Physical Training

24 sessions (8 weeks, 3 times per week) of computer based 45 minute cognitive and 45 minute physical training.

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type OTHER

Cognitive training included memory, attention, velocity, intelligence

Physical Training

Intervention Type OTHER

Physical training included aerobic, strength, flexibility and balance.

Interventions

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Cognitive Training

Cognitive training included memory, attention, velocity, intelligence

Intervention Type OTHER

Physical Training

Physical training included aerobic, strength, flexibility and balance.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* a diagnosis of schizophrenia disorder according to ICD10 criteria
* clinically stable patients (no recent change in psychotropic medication except benzodiazepines)
* sufficient acculturation and fluency in Greek language
* assent of the attending physician for participation in the study

Exclusion Criteria

* co-morbidity with neurological disorders (e.g.epilepsy) or head injury
* a pathological or other somatic disorder that contraindicate physical exercise
* alcoholism and substance abuse within the previous 3 months (except caffeine and tobacco)
* abstainance from intervention for more than 12 days
* cognitive decline
* treated with Benzodiazepine
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Panos Bamidis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panagiotis Bamidis, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Laboratory of Medical Physics, AUTH

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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Hemsley DR. The development of a cognitive model of schizophrenia: placing it in context. Neurosci Biobehav Rev. 2005;29(6):977-88. doi: 10.1016/j.neubiorev.2004.12.008.

Reference Type BACKGROUND
PMID: 15964074 (View on PubMed)

Tagliazucchi E, von Wegner F, Morzelewski A, Borisov S, Jahnke K, Laufs H. Corrigendum to "Automatic sleep staging using fMRI functional connectivity data" [Neuroimage 63/1 (2012) 63-72]. Neuroimage. 2013 Nov 1;81:506. doi: 10.1016/j.neuroimage.2013.05.048. Epub 2013 May 23. No abstract available.

Reference Type BACKGROUND
PMID: 30180376 (View on PubMed)

Frantzidis CA, Vivas AB, Tsolaki A, Klados MA, Tsolaki M, Bamidis PD. Functional disorganization of small-world brain networks in mild Alzheimer's Disease and amnestic Mild Cognitive Impairment: an EEG study using Relative Wavelet Entropy (RWE). Front Aging Neurosci. 2014 Aug 26;6:224. doi: 10.3389/fnagi.2014.00224. eCollection 2014.

Reference Type BACKGROUND
PMID: 25206333 (View on PubMed)

Konstantinidis EI, Billis AS, Mouzakidis CA, Zilidou VI, Antoniou PE, Bamidis PD. Design, Implementation, and Wide Pilot Deployment of FitForAll: An Easy to use Exergaming Platform Improving Physical Fitness and Life Quality of Senior Citizens. IEEE J Biomed Health Inform. 2016 Jan;20(1):189-200. doi: 10.1109/JBHI.2014.2378814.

Reference Type BACKGROUND
PMID: 26731797 (View on PubMed)

Whitfield-Gabrieli S, Thermenos HW, Milanovic S, Tsuang MT, Faraone SV, McCarley RW, Shenton ME, Green AI, Nieto-Castanon A, LaViolette P, Wojcik J, Gabrieli JD, Seidman LJ. Hyperactivity and hyperconnectivity of the default network in schizophrenia and in first-degree relatives of persons with schizophrenia. Proc Natl Acad Sci U S A. 2009 Jan 27;106(4):1279-84. doi: 10.1073/pnas.0809141106. Epub 2009 Jan 21.

Reference Type BACKGROUND
PMID: 19164577 (View on PubMed)

Arbabshirani MR, Kiehl KA, Pearlson GD, Calhoun VD. Classification of schizophrenia patients based on resting-state functional network connectivity. Front Neurosci. 2013 Jul 30;7:133. doi: 10.3389/fnins.2013.00133. eCollection 2013.

Reference Type RESULT
PMID: 23966903 (View on PubMed)

Bamidis PD, Fissler P, Papageorgiou SG, Zilidou V, Konstantinidis EI, Billis AS, Romanopoulou E, Karagianni M, Beratis I, Tsapanou A, Tsilikopoulou G, Grigoriadou E, Ladas A, Kyrillidou A, Tsolaki A, Frantzidis C, Sidiropoulos E, Siountas A, Matsi S, Papatriantafyllou J, Margioti E, Nika A, Schlee W, Elbert T, Tsolaki M, Vivas AB, Kolassa IT. Gains in cognition through combined cognitive and physical training: the role of training dosage and severity of neurocognitive disorder. Front Aging Neurosci. 2015 Aug 7;7:152. doi: 10.3389/fnagi.2015.00152. eCollection 2015.

Reference Type RESULT
PMID: 26300772 (View on PubMed)

Frantzidis CA, Ladas AK, Vivas AB, Tsolaki M, Bamidis PD. Cognitive and physical training for the elderly: evaluating outcome efficacy by means of neurophysiological synchronization. Int J Psychophysiol. 2014 Jul;93(1):1-11. doi: 10.1016/j.ijpsycho.2014.01.007. Epub 2014 Jan 25.

Reference Type RESULT
PMID: 24472698 (View on PubMed)

Rosazza C, Minati L. Resting-state brain networks: literature review and clinical applications. Neurol Sci. 2011 Oct;32(5):773-85. doi: 10.1007/s10072-011-0636-y. Epub 2011 Jun 11.

Reference Type RESULT
PMID: 21667095 (View on PubMed)

Other Identifiers

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SCH15973

Identifier Type: -

Identifier Source: org_study_id

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