Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

Metabolic Syndrome Clinical Trial

Official title:

Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658354
• Other study ID #: 27819
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: University of Ioannina
• Contact: Konstantinos K Tsilidis, Associate Professor
• Phone: 26510 0 7734
• Email: ktsilidi[@]uoi.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate the possibility of rehabilitation of mild cognitive deficits in people with metabolic syndrome. We aim to implement a cognitive training program on patients with metabolic syndrome and cognitive deficits, and examine its effectiveness both post-intervention (3 months) and after 12 months.

Researchers will compare two groups, the experimental group that will receive the computerized cognitive training and the control group that will receive no training.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Presence of metabolic syndrome according to the criteria of IDF (2005) or revised NCEP-ATP III (2005)

• Presence of mild cognitive deficit (-1.5 SD below age and education-adjusted normative mean) in previously administered neuropsychological tests of Trail Making test (Part A & B), Verbal Fluency test (animals and letter "x"), Logical Memory test (immediate and delayed recall)

• Written informed consent to participate

Exclusion Criteria:

• Presence of any serious neurological or psychiatric condition

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Cognitive Dysfunction
• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Computerized cognitive program
BrainHQ was developed by Posit Science and includes computer-based brain-training exercises organized into six categories: Attention, Brain Speed, Memory, People Skills, Intelligence, and Navigation. Participants were instructed to perform a total of 24 sessions of computerized cognitive training at home, consisting of 45 minutes of training, twice per week, over a 3-month period.

Locations

Country	Name	City	State
Greece	Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina	Ioánnina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scores of the Montreal Cognitive Assessment (MoCA) test	MoCA is a screening test for mild cognitive dysfunction; range 0-30, higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of Complex Figure tests	Complex Figures assess visuo-constructional ability and visual memory; range 0-36, higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)	HVLT-R assesses verbal memory using a list of words; range 0-36 (immediate recall) and range 0-12 (delayed recall), higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of Digit Span test	Digit Span assesses working memory; range 0-14 (performance) and range 2-9 (span) for forward and backward condition, higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of semantic Verbal Fluency test	Verbal Fluency assesses executive function that also relies on language component; higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of Flanker task	Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of Continuous Performance Test (CPT)	CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of Set Shifting	Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Primary	Change in scores of N-back	N-back assesses working memory; range 0-30, higher scores represent better cognitive function	baseline, post-intervention (3 months), follow-up (1 year from baseline)
Secondary	Change in scores of Everyday Cognition-II (Ecog-II)	Ecog-II is a measure of everyday functioning that includes 41 items to assess memory, language, visual, spatial and perceptual abilities, planning, organization, and divided attention; higher scores represent worse everyday functioning	baseline, follow-up (1 year from baseline)