NCT02790151

Brief Summary

Memory deficits after brain damage are common and there is still a need for evaluated therapy methods. In this study we compare two therapeutic interventions and investigate whether therapy effects can be found on neuropsychological tests and on a test measuring memory in everyday life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

March 2, 2015

Last Update Submit

October 17, 2016

Conditions

Memory Deficits

Keywords

working memory, recollection training, transfer

Outcome Measures

Primary Outcomes (1)

  • Test to assess change in memory performance in everyday life

    The test includes different single tasks that measure memory in everyday life e.g. Story recall (Subtest 6 from the Rivermead Behavioral Memory Test) Outcome measure: Total number of points

    baseline and 9 hours

Secondary Outcomes (1)

  • Outcome change in different neuropsychological tests

    baseline and 9 hours

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Learning and practicing memory strategies

Behavioral: Standard Therapy

Experimental Intervention

EXPERIMENTAL

Computerbased working memory training and Recollection training

Behavioral: Experimental Intervention

Interventions

Standard TherapyBEHAVIORAL

Learning and practicing Memory strategies

Standard Therapy
Experimental InterventionBEHAVIORAL

Computerbased Working Memory Training in Combination with a Recollection Training

Experimental Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • brain injury
  • memory deficits (performance below average in the California Verbal Learning Test in learning trial 1 or 5, sfr or lfr)

You may not qualify if:

  • severe amnesia (less than 2 words in sfr of the CVLT), dementia, sensory or motor aphasia, impaired vision, insufficient German language skills, lack of patient's consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitationszentrum GmbH

Oldenburg, Deutschland, 26131, Germany

Location

Related Publications (1)

  • Richter KM, Modden C, Eling P, Hildebrandt H. Improving everyday memory performance after acquired brain injury: An RCT on recollection and working memory training. Neuropsychology. 2018 Jul;32(5):586-596. doi: 10.1037/neu0000445. Epub 2018 Apr 26.

    PMID: 29697993DERIVED

MeSH Terms

Conditions

Memory Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Helmut Hildebrandt, Prof. Dr.

    Universität Oldenburg

    STUDY DIRECTOR

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
MSc Psychologie

Study Record Dates

First Submitted

March 2, 2015

First Posted

June 3, 2016

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

DE(1)