NCT02399293

Brief Summary

Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with acquired brain injury and non-impaired subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

March 11, 2015

Last Update Submit

March 20, 2015

Conditions

Keywords

Cognitive trainingCognitive rehabilitationAcquired brain injuryN-backVisual SearchCognitive transfer

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Raven's advanced progressive matrices at the end of training

    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.

Secondary Outcomes (5)

  • Change from baseline WAIS-III Working Memory Index at the end of training

    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.

  • Change from baseline WAIS-III Processing Speed Index at the end of training

    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.

  • Change from baseline Operation Span at the end of training

    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.

  • Change from baseline Stroop color-text interference at the end of training

    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.

  • Change from baseline AMPS at the end of training

    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.

Study Arms (4)

Patient N-back

EXPERIMENTAL

Patients training the N-back task

Behavioral: N-back

Patient Visual Search

ACTIVE COMPARATOR

Patients training the Visual-Search task

Behavioral: Visual Search

Non-impaired N-back

EXPERIMENTAL

Non-impaired training the N-back task

Behavioral: N-back

Non-impaired Visual Search

ACTIVE COMPARATOR

Non-impaired training the Visual-Search task

Behavioral: Visual Search

Interventions

N-backBEHAVIORAL

The N-back task required patients to monitor a continuous sequence of stimuli (in this experiment audio and visual stimuli). Press a button if the current stimulus is the same as that shown N back in the sequence. N increases if performance is good and decreases if performance is poor. Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.

Non-impaired N-backPatient N-back
Visual SearchBEHAVIORAL

The Visual Search task consists of a NxN array of shapes. Press the button if a certain target stimulus is present in this array. N increases if performance is good and decreases if performance is poor. Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.

Non-impaired Visual SearchPatient Visual Search

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects should be able to do both task at level at the time of recruitment
  • Informed consent
  • (for brain injured patients) training must not interfere with treatment as usual.
  • (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jonas Lindeløv, M.Sc.

    Hammel Neurocenter

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 26, 2015

Study Start

April 1, 2013

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03