NCT02193906

Brief Summary

The purpose of the study is to determine the effect of an web-based intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

September 18, 2013

Last Update Submit

July 16, 2014

Conditions

Cognitive Dysfunction

Keywords

Cognitive trainingMultiple sclerosisCognitive deficits

Outcome Measures

Primary Outcomes (1)

  • Effect of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.

    Two neuropsychological assessments were made: at baseline and at 3 months with the same neuropsychological battery to all the patients. After that, the statistically significant differences between the two study groups (comparing the standard deviations from the normative values of each test), will be accessed. The tests will be analysed separately and globally as a battery.

    3 months

Secondary Outcomes (6)

  • Neuropsychological profile of a population of patients with multiple sclerosis or clinical isolated syndrome.

    Baseline

  • Percentage of patients with Cognitive Dysfunction

    Baseline

  • Relation between Expended Disability Status Scale score and cognitive dysfunction.

    Baseline

  • Impact of depression on neuropsychological performance.

    Baseline

  • Relation between cognitive dysfunction and the 9-hole peg test.

    Baseline

  • +1 more secondary outcomes

Other Outcomes (1)

  • Long term effects of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with Expended Disability Status Scale.

    9 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Cognitive training.

Other: Cognitive training

Placebo group

PLACEBO COMPARATOR

Placebo task.

Other: Placebo task

Interventions

Cognitive trainingOTHER

Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients who have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb® during 3 months. Patients who don't have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb Monthly Notebooks® during 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.

Intervention group
Placebo taskOTHER

Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients will have to complete a placebo task (send an email with a copy of a journal/magazine heading) a minimum of 3 times a week, for 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with MS diagnosed according to McDonald criteria from 2010 and clinical isolated syndrome patients.
  • Age ≥18 years old.
  • Informed consent.

You may not qualify if:

  • Disease relapse in the last month.
  • Corticotherapy in the last month.
  • Expended Disability Status Scale score \>6,0.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionMultiple SclerosisCognition Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vitor T Cruz, MD

    Clinical Research Office - Health Sciences Department

    STUDY DIRECTOR

  • Ivânia A Alves, MD

    Clinical Research Office, Health Sciences Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 18, 2013

First Posted

July 18, 2014

Study Start

December 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07