Investigating Visuo-spatial Abilities and Psychological Effects in West Nile and Multiple Sclerosis Patients with a Focus on a Possible Rehabilitation Protocol

NCT06640660 | Recruiting DMC

• 1 other identifier: 2022.11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate visuospatial abilities and psychological outcomes in patients with multiple scleroris (MS) and patients with West Nile virus infection (vWN). Patients will undergo a specific neuropsychological and psychological evaluation. Afterwards, patients will receive 10 sessions of cognitive training integrating digital exercises and prismatic lenses. At the end of the treatment, patients will be re-evaluated to explore for potential changes in the cognitive and psychological profile.

Conditions

Multiple Sclerosis; West Nile Virus

Keywords

neurological patients; cognitive training; neuropsychology

Outcome Measures

Primary Outcomes (1)

• Measure of changes in cognitive performance after the treatment

  Cognitive performances will be assessed by a full neuropsychological battery encompassing the main cognitive domain, such as memory, attention, executive function, language, visuospatial abilities. Specific neuropsychological tests will be defined on the basis of the specific neurological population. Raw scores at each test and scale will be converted in z-scores based on each test/scale normative data. Z-scores will be averaged to calculate composite scores specific for each cognitive domain and for motor functioning. In detail, the composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language.

  At baseline and after 2 weeks (post-intervention)

Secondary Outcomes (1)

• Measure of changes in psychological aspects after the treatment

  At baseline and after 2 weeks (post-intervention)

Study Arms (2)

MindLenses Group

EXPERIMENTAL

The group will undergo 10 sessions (2 weeks) of a treatment combining prismatic adaptation (PA) and serious games (SG) for cognitive training, using the Mindlenses Professional device. In each session, the PA procedure will be performed, followed by approximately 30 minutes of SG. SG will be focused on attention, executive functions and language.

Device: Mindlenses Professional

Control Group

ACTIVE COMPARATOR

The group will perform 2 weeks of the standard cognitive training offered by IRCCS San Camillo Hospital.

Behavioral: Conventional rehabilitation

Interventions

Mindlenses Professional DEVICE

MindLenses professional's device combines the prismatic adaptation (PA) procedure with the administration of serious games (SG) for cognitive training using a tablet

MindLenses Group

Conventional rehabilitation BEHAVIORAL

Conventional rehabilition consists in computerized exercises focused on the main cognitive domains

Control Group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of: Multiple Scleroris OR vWN infection ascertained by laboratory analysis and received no later than twelve months prior to the date of hospitalization
• preserved use of at least one hand
• normal or corrected to normal vision

You may not qualify if:

• history of psychiatric and/or concurrent neurological diseases
• inability to provide informed consent,
• impaired comprehension of oral instructions,

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo Hospital

Lido, Venezia, 30126, Italy

RECRUITING

Related Publications (8)

• Bracco M, Mangano GR, Turriziani P, Smirni D, Oliveri M. Combining tDCS with prismatic adaptation for non-invasive neuromodulation of the motor cortex. Neuropsychologia. 2017 Jul 1;101:30-38. doi: 10.1016/j.neuropsychologia.2017.05.006. Epub 2017 May 6.

  PMID: 28487249 BACKGROUND

• Carson PJ, Konewko P, Wold KS, Mariani P, Goli S, Bergloff P, Crosby RD. Long-term clinical and neuropsychological outcomes of West Nile virus infection. Clin Infect Dis. 2006 Sep 15;43(6):723-30. doi: 10.1086/506939. Epub 2006 Aug 10.

  PMID: 16912946 BACKGROUND

• Chiaravalloti ND, DeLuca J, Moore NB, Ricker JH. Treating learning impairments improves memory performance in multiple sclerosis: a randomized clinical trial. Mult Scler. 2005 Feb;11(1):58-68. doi: 10.1191/1352458505ms1118oa.

  PMID: 15732268 BACKGROUND

• Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.

  PMID: 19007738 BACKGROUND

• Hayes EB, Sejvar JJ, Zaki SR, Lanciotti RS, Bode AV, Campbell GL. Virology, pathology, and clinical manifestations of West Nile virus disease. Emerg Infect Dis. 2005 Aug;11(8):1174-9. doi: 10.3201/eid1108.050289b.

  PMID: 16102303 BACKGROUND

• Magnani B, Caltagirone C, Oliveri M. Prismatic adaptation as a novel tool to directionally modulate motor cortex excitability: evidence from paired-pulse TMS. Brain Stimul. 2014 Jul-Aug;7(4):573-9. doi: 10.1016/j.brs.2014.03.005. Epub 2014 Apr 13.

  PMID: 24934876 BACKGROUND

• Pisella L, Rode G, Farne A, Tilikete C, Rossetti Y. Prism adaptation in the rehabilitation of patients with visuo-spatial cognitive disorders. Curr Opin Neurol. 2006 Dec;19(6):534-42. doi: 10.1097/WCO.0b013e328010924b.

  PMID: 17102690 BACKGROUND

• Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.

  PMID: 2027484 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: October 15, 2024
• Study Start: September 21, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)