NCT02220816

Brief Summary

Within a prospective, randomised, controlled study 60, selected patients with chronic (\> 6 months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of competitive versus non-competitive attentional training. Competitive training will include fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations and fifteen 1-hour sessions of competitive attentional games designed for this purpose using a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED array to facilitate multi-touch experience embedded in a conventional table). Progress will be evaluated by pre and post measurement of attentional neuropsychological tests, subjective reports of global attention, usability and motivational scales. Our hypothesis is that competitive training is more effective in improving attention than conventional training in the chronic phase after acquired brain injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

August 18, 2014

Last Update Submit

August 18, 2015

Conditions

StrokeBrain Injuries

Keywords

AttentionCompetitiveTraining

Outcome Measures

Primary Outcomes (1)

  • Change in attentional psychometric measures

    Neuropsychological battery: Conner's Continuous Performance Test (CPT-II), Color-Trail Test, d2, Stroop test, Wechsler Adult Intelligence Scale-IV digit-span, Corsi block-tapping test

    Baseline versus end of treatment (an expected average of 8 weeks)

Secondary Outcomes (1)

  • Usability measures

    Baseline versus end of treatment (an expected average of 8 weeks)

Other Outcomes (1)

  • Family-centered outcomes

    Baseline versus end of treatment (an expected average of 8 weeks)

Study Arms (2)

Competitive Training

EXPERIMENTAL

The patients will receive only competitive activities designed to restore attention abilities. These include pencil-and-paper tasks completed under competitive circumstances and competitive virtual games specifically designed to treat different aspects of attention (divided, selective, sustained, etc).

Behavioral: Competitive training

Non-Competitive Training

ACTIVE COMPARATOR

The patients will receive conventional attentional training. Pencil and paper tasks focused on different aspects of attention (divided, selective, sustained, etc.) will be completed by all participant under individual or group-therapy sessions. No competitive training will be allowed.

Behavioral: Non-Competitive Training

Interventions

Competitive trainingBEHAVIORAL

30 sessions of competitive cognitive training; 3 - 5 sessions/week; duration 45 min

Competitive Training
Non-Competitive TrainingBEHAVIORAL

30 sessions of non-competitive cognitive training; 3 - 5 sessions/week; duration 45 min

Non-Competitive Training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acquired brain injury patients (stroke and traumatic brain injury)
  • Chronicity \> 6 months
  • More than 3 months under cognitive rehabilitation
  • Mississippi Aphasia Screening Test (comprehension subtest \> 45)

You may not qualify if:

  • Severe cognitive impairment defined as \< 23 on Mini Mental Status Examination
  • Unable to give informed consent
  • Visual or auditive disorders limiting the ability to comply with treatment regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospitales NISA

Valencia, Valencia, 46011, Spain

Location

MeSH Terms

Conditions

StrokeBrain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Roberto Llorens, PhD

    Universitat Politècnica de València

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

ES(1)