Memory DeficitsNCT02790151
Memory Rehabilitation by Means of Working Memory Training in Combination With a Recollection Training
A study testing Standard Therapy and Experimental Intervention in people with Memory Deficits, run by University of Oldenburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Memory Deficits
- What is being tested?
- Standard Therapy and Experimental Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- brain injury
- memory deficits (performance below average in the California Verbal Learning Test in learning trial 1 or 5, sfr or lfr)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Memory Rehabilitation by Means of Working Memory Training in Combination
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.
Read the detailed description
In the interventiongroup a computerbased working memory training is combined with a recollection training (repitition-lag procedure). The patients in the active control group undergo the standard memory therapy that is normally provided in the rehabilitation centre (with a focus on the acquisition and execution of different memory strategies, e.g. the spaced retrieval method). The patients in both groups are tested on different neuropsychological tests before and after nine hours of therapy. Additionally, a test is conducted that assesses memory in everyday life.
- Conditions
- Memory Deficits
- Being tested
- Standard Therapy, Experimental Intervention
- Keywords
- working memory, recollection training, transfer
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TherapyBehavioural
Learning and practicing Memory strategies
Experimental InterventionBehavioural
Computerbased Working Memory Training in Combination with a Recollection Training
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Learning and practicing memory strategies Receives: Behavioral: Standard Therapy |
| Experimental Intervention | Experimental | Computerbased working memory training and Recollection training Receives: Behavioral: Experimental Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 9 hours
Secondary outcomes (1)
Outcome change in different neuropsychological tests
Tests for verbal memory, working memory, prospective memory, attention and word fluency (Composite scores built from raw scores)
Measured: baseline and 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory DeficitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oldenburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Merle Richter, University of Oldenburg
- Investigators
- Helmut Hildebrandt, Prof. Dr., Study director, Universität Oldenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790151
- Sponsor's protocol ID
- UOLDENBURG
- Status last verified
- Oct 2016
- First submitted
- 2 Mar 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29697993
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Rehabilitation by Means of Working Memory Training in Combination
- ClinicalTrials.gov ID
- NCT02790151
- Acronym / sponsor ID
- UOLDENBURG
- Conditions
- Memory Deficits
- Keywords
- working memory, recollection training, transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of OldenburgUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the interventiongroup a computerbased working memory training is combined with a recollection training (repitition-lag procedure). The patients in the active control group undergo the standard memory therapy that is normally provided in the rehabilitation centre (with a focus on the acquisition and execution of different memory strategies, e.g. the spaced retrieval method). The patients in both groups are tested on different neuropsychological tests before and after nine hours of therapy. Additionally, a test is conducted that assesses memory in everyday life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Behavioral: Standard TherapyLearning and practicing memory strategies |
| Experimental Intervention | Experimental | Behavioral: Experimental InterventionComputerbased working memory training and Recollection training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- brain injury
- memory deficits (performance below average in the California Verbal Learning Test in learning trial 1 or 5, sfr or lfr)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TherapyLearning and practicing Memory strategies | Behavioural | Standard Therapy |
| Experimental InterventionComputerbased Working Memory Training in Combination with a Recollection Training | Behavioural | Experimental Intervention |
Primary outcome
Test to assess change in memory performance in everyday life
Time frame: baseline and 9 hours
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
1 secondary outcome
Outcome change in different neuropsychological tests
Time frame: baseline and 9 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Derived from this study: PubMed 29697993Richter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Hildebrandt, Prof. Dr. study director
Universität Oldenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Therapy and Experimental Intervention in people with Memory Deficits, run by University of Oldenburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test to assess change in memory performance in everyday life (time frame: baseline and 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.