Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

Schizophrenia Clinical Trial

Official title:

A Neurophysiological Investigation of the Effectiveness of Web-based Exergaming Platform of Cognitive and Physical Training in Schizophrenic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899662
• Other study ID #: SCH15973
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2020
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neurophysilogical, neuropsychological evaluation and cognitive and physical training

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Cognitive Training
Cognitive training included memory, attention, velocity, intelligence
• Physical Training
Physical training included aerobic, strength, flexibility and balance.

Locations

Country	Name	City	State
Greece	Laboratory of Medical Physics, AUTH	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (9)

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. — View Citation

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, Papa — View Citation

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.2014.0 — View Citation

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. — View Citation

Hemsley DR. The development of a cognitive model of schizophrenia: placing it in context. Neurosci Biobehav Rev. 2005;29(6):977-88. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: Proc Natl Acad Sci U S A. 2009 Mar 17;106(11):4572. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alterations in functional connectivity properties and on the organization of resting state networks	Alterations in functional connectivity properties and on the organization of resting state networks quantified through graph theory tools. These measures would be measured through high-density electroencephalographic (EEG) evaluation and reconstruction of cortical activity.	3 months
Secondary	Physical fitness	Estimated through 6-Minute Walking Distance (6MWD)	2 months
Secondary	Physical fitness	Estimated through ???	2 months
Secondary	Physical fitness	Estimated through HandGrip Strength Test	2 months
Secondary	Physical fitness	Estimated through Short Physical Performance Battery Protocol	2 months
Secondary	Memory	Estimated through Wechsler Memory - Cubes (visuospatial) test	2 months
Secondary	Executive function	Estimated through FAB (Frontalassesment test)	2 months
Secondary	Depressive syndromes	Estimated through Had's test	2 months
Secondary	Theory of mind	Estimated through Eye's test	2 months
Secondary	Verbal fluency	Estimated through Verbal Fluency test	2 months
Secondary	Visual attention and task switching	Estimated through Trail Making A & B test	2 months
Secondary	Reaction time	Estimated through Stroop test	2 months
Secondary	Generic cogntive impairment	Estimated through Montreal Cognitive Assessment (MoCA) test	2 months