Cognitive DeclineDIINNCT03228446
The Effects of Attentional Filter Training on Working Memory
A study testing filter training and memory training in people with Cognitive Decline and Healthy, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
Trial summary
The investigators are interested in how attentional filter training/ distractor inhibition training could influence cognitive functions like working memory, executive control, problem solving, decision making and attentional control. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Healthy, Age-related Cognitive Decline
- What is being tested?
- filter training and memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 26 Sep 2012to Jan 2019
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- right-hander
- aged between 18-30 or 60-80years
Who cannot join
- severe visual impairments (e.g. dyschromatopsia, very low vision)
- diseases or medication that might impair test performance
- Montreal Cognitive Assessment Score (MoCA) < 26 points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Cognitive Functions by Training Distractor Inhibition (DIIN) in Younger and Older Healthy Adults
The investigators are interested in how attentional filter training/ distractor inhibition training could influence cognitive functions like working memory, executive control, problem solving, decision making and attentional control.
Read the detailed description
Two different computer based trainings were applied: an attentional filter training and a working memory training.
- Conditions
- Cognitive Decline, Healthy, Age-related Cognitive Decline
- Being tested
- filter training, memory training, no training (control)
- Keywords
- training intervention, filter training, distractor inhibition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filter trainingBehavioural
one-week filter training on the computer: computerized visual change detection experiment (selective attention )
memory trainingBehavioural
one-week storage training on the computer: computerized visual change detection experiment (memory storage)
no training (control)Other
no training applied
| Study group | Role | What they receive |
|---|---|---|
| Young subjects | Experimental | Working memory training \& attentional filter training for participants (18-30 years) Receives: Behavioral: filter training; Behavioral: memory training |
| Old subjects | Experimental | Working memory training, attentional filter training and no training (control) for participants (60-80 years) Receives: Behavioral: filter training; Behavioral: memory training; Other: no training (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in test performance
Working memory and filtering performance (in %), effects of distractor interference and reaction times for trials with and without distractors with 4, 5 \& 6 targets
Measured: 45min pre / post
Secondary outcomes (14)
Rey Complex Figure Test
Copying complex figures and reproduce it from memory
Measured: 30min pre / post
Memory from TAP (Test battery of Attentional Performance)
Working Memory (n-back)
Measured: 45min pre / post
Attention from TAP (Test battery of Attentional Performance)
divided attention, Go-NoGo, Flexibility, Incompatibility, Visual scanning
Measured: 45min pre / post
Performance in repeating numbers
Repeating numbers in forward \& backward conditions
Measured: 10min pre / post
Subtest from CANTAB (Cambridge Neuropsychological Test Automated Battery)
Spatial Span Test
Measured: 10min pre / post
Iowa Gambling Task
Decision making
Measured: 5min on each training day (1-5)
Daily Questionnaires
subjective performance in the training paradigm
Measured: 2 min on each training day (1-5)
Daily Questionnaires
Assessing external circumstances of daily influences
Measured: 2min on each training day (1-5)
Memory performance without distractors among different setsizes
Working memory performance (in %) for trials with 4, 5 \& 6 targets and averaged performance for all conditions without distractors
Measured: 45min pre / post
Memory performance with distractors among different setsizes
Working memory performance (in %) for trials with 4, 5 \& 6 targets and distractors and averaged performance for all conditions with distractors
Measured: 45min pre / post
Filtering performance without distractors among different setsizes
Filtering performance (in %) for trials with 4, 5 \& 6 targets and averaged performance for all conditions without distractors
Measured: 45min pre / post
Filtering performance with distractors among different setsizes
Filtering performance (in %) for trials with 4, 5 \& 6 targets and distractors and averaged performance for all conditions with distractors
Measured: 45min pre / post
Reaction times
Reaction times in each condition
Measured: 45min pre / post
Values of distractor inhibition
Distractor inhibition (DIIN) = Mean of conditions without distractors - Mean of conditions with distractors
Measured: 45min pre / post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start26 Sep 2012
- Primary completionDec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Notger Müller, German Center for Neurodegenerative Diseases (DZNE)
- Investigators
- Notger Müller, Prof. Dr., Principal investigator, German Center for Neurodegenerative Diseases (DZNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228446
- Sponsor's protocol ID
- MD021
- Acronym
- DIIN
- Status last verified
- Feb 2019
- First submitted
- 12 Jul 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmicker M, Schwefel M, Vellage AK, Muller NG. Training of Attentional Filtering, but Not of Memory Storage, Enhances Working Memory Efficiency by Strengthening the Neuronal Gatekeeper Network. J Cogn Neurosci. 2016 Apr;28(4):636-42. doi: 10.1162/jocn_a_00922. Epub 2016 Jan 14.
PubMed 26765946Schmicker M, Muller P, Schwefel M, Muller NG. Attentional Filter Training but Not Memory Training Improves Decision-Making. Front Hum Neurosci. 2017 Mar 23;11:138. doi: 10.3389/fnhum.2017.00138. eCollection 2017.
PubMed 28386225
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cognitive Functions by Training Distractor Inhibition (DIIN) in Younger and Older Healthy Adults
- ClinicalTrials.gov ID
- NCT03228446
- Acronym / sponsor ID
- DIIN / MD021
- Conditions
- Cognitive Decline, Healthy, Age-related Cognitive Decline
- Keywords
- training intervention, filter training, distractor inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 26 Sep 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 25 Jul 2017 (actual)
- 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.
The investigators are interested in how attentional filter training/ distractor inhibition training could influence cognitive functions like working memory, executive control, problem solving, decision making and attentional control.
Detailed description
Two different computer based trainings were applied: an attentional filter training and a working memory training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young subjects | Experimental | Behavioral: filter training, Behavioral: memory trainingWorking memory training \& attentional filter training for participants (18-30 years) |
| Old subjects | Experimental | Behavioral: filter training, Behavioral: memory training, Other: no training (control)Working memory training, attentional filter training and no training (control) for participants (60-80 years) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- right-hander
- aged between 18-30 or 60-80years
Key exclusion criteria (3 listed)
- severe visual impairments (e.g. dyschromatopsia, very low vision)
- diseases or medication that might impair test performance
- Montreal Cognitive Assessment Score (MoCA) < 26 points
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 |
|---|---|---|
| filter trainingone-week filter training on the computer: computerized visual change detection experiment (selective attention ) | Behavioural | Old subjects, Young subjects |
| memory trainingone-week storage training on the computer: computerized visual change detection experiment (memory storage) | Behavioural | Old subjects, Young subjects |
| no training (control)no training applied | Other | Old subjects |
Primary outcome
Improvements in test performance
Time frame: 45min pre / post
Working memory and filtering performance (in %), effects of distractor interference and reaction times for trials with and without distractors with 4, 5 \& 6 targets
14 secondary outcomes
Rey Complex Figure Test
Time frame: 30min pre / post
Memory from TAP (Test battery of Attentional Performance)
Time frame: 45min pre / post
Attention from TAP (Test battery of Attentional Performance)
Time frame: 45min pre / post
Performance in repeating numbers
Time frame: 10min pre / post
Subtest from CANTAB (Cambridge Neuropsychological Test Automated Battery)
Time frame: 10min pre / post
Iowa Gambling Task
Time frame: 5min on each training day (1-5)
Daily Questionnaires
Time frame: 2 min on each training day (1-5)
Daily Questionnaires
Time frame: 2min on each training day (1-5)
Memory performance without distractors among different setsizes
Time frame: 45min pre / post
Memory performance with distractors among different setsizes
Time frame: 45min pre / post
Filtering performance without distractors among different setsizes
Time frame: 45min pre / post
Filtering performance with distractors among different setsizes
Time frame: 45min pre / post
Reaction times
Time frame: 45min pre / post
Values of distractor inhibition
Time frame: 45min pre / post
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 15 Feb 2019.
- Results publication: PubMed 26765946Schmicker M, Schwefel M, Vellage AK, Muller NG. Training of Attentional Filtering, but Not of Memory Storage, Enhances Working Memory Efficiency by Strengthening the Neuronal Gatekeeper Network. J Cogn Neurosci. 2016 Apr;28(4):636-42. doi: 10.1162/jocn_a_00922. Epub 2016 Jan 14.
- Results publication: PubMed 28386225Schmicker M, Muller P, Schwefel M, Muller NG. Attentional Filter Training but Not Memory Training Improves Decision-Making. Front Hum Neurosci. 2017 Mar 23;11:138. doi: 10.3389/fnhum.2017.00138. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Notger Müller, Prof. Dr. principal investigator
German Center for Neurodegenerative Diseases (DZNE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filter training and memory training in people with Cognitive Decline and Healthy, run by German Center for Neurodegenerative Diseases (DZNE) 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 3 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 15 Feb 2019. 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?
Improvements in test performance (time frame: 45min pre / post). 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 NCT03228446, which also lists 2 linked publications.
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 15 Feb 2019.