Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis

NCT02287454 | Completed DMC

• 1 other identifier: NSMC-002-UD
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The study design was a parallel-group randomized trial with equal randomization. Recruitment and enrollment were conducted between January 2013 and March 2013. At base-line, cognitive data was collected. Afterwards, the participants were randomly allocated to either the REHACOP group or the Control group. During 3 months the intervention with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate the change in cognitive measure. Post-treatment assessment (finished by July 2013) was performed within the first week after completing the intervention. Optional enrollment in pre-post neuroimaging will also allow us to look at changes in the brain. Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to improve cognition of patients with Multiple Sclerosis (MS).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, cognitive rehabilitation, REHACOP

Outcome Measures

Primary Outcomes (6)

• Change in attention after receiving cognitive rehabilitation treatment

  Attention was measured using the Brief Test of Attention (BTA).

  3 months

• Change in working memory after receiving cognitive remediation treatment

  Working memory was measured using the Backward Digits (BD) subtest of the Wechsler Adult Intelligence Scale III.

  3 months

• Change in processing speed after receiving cognitive remediation treatment

  Processing speed was measured using a composite score which included the Symbol Digit Modalities Test (SDMT), the three and six letter version of the Salthouse Perceptual Comparison Test (PCT) and the Trail Making Test A (TMTA).

  3 months

• Change in verbal memory after receiving cognitive remediation treatment

  Verbal memory was measured using The Hopkins Verbal Learning Test - Revised (HVLT-R).

  3 months

• Change in verbal fluency after receiving cognitive remediation treatment

  Verbal fluency was measured using the Calibrated Ideational Fluency Assessment (CIFA).

  3 months

• Change in executive functioning after receiving cognitive remediation treatment.

  Executive functioning was measured with the Stroop Color-Word Test.

  3 months

Study Arms (2)

Cognitive remediation program: REHACOP

EXPERIMENTAL

Cognitive rehabilitation program (REHACOP) including intervention in: attention, memory, processing speed, language, executive functioning and social cognition during 3 months, 3 times per week

Other: cognitive remediation program: REHACOP

Control group

NO INTERVENTION

No intervention was administered.

Interventions

cognitive remediation program: REHACOP OTHER

Specifically, REHACOP group remediation with MS patients consisted of: four weeks training attention (sustained, selective, alternating and divided attention); three weeks focused on learning and memory (the stimulation of verbal and visual memory was combined with learning and compensatory strategies, working memory was also trained); three weeks exercising executive functioning (development, planning and attainment of objectives); three weeks focused on language (verbal fluency, syntax, grammar, vocabulary and comprehension); and one week training social cognition (social reasoning, theory of mind and moral dilemmas).

Cognitive remediation program: REHACOP

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• i) age 20-60 years
• ii) either male or female
• iii) patients with relapsing-remitting, secondary progressive or primary progressive MS

You may not qualify if:

• i) presence of dementia
• ii) have suffered an exacerbation during the previous month to the cognitive assessment
• iii) being treated with corticosteroids
• iv) presence of other neurological disorder
• v) history of stroke or traumatic brain injury resulting in more than 30 minutes loss of consciousness
• vi) presence of psychiatric disorders

Sponsors & Collaborators

• University of Deusto: lead

Study Sites (1)

University of Deusto

Bilbao, Biskai, 48007, Spain

Location

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 Officials

• Naroa Ibarretxe-Bilbao, Doctor

  University of Deusto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: November 10, 2014
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

ES (1)