Mild Cognitive ImpairmentCATSNCT02587338
Cognitive Ability Training in Seniors
A study testing Verum tDCS in people with Mild Cognitive Impairment, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probands which were randomized into verum or… Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Verum tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- native german speaker
- between 60-70 years old
- subjective memory impairment
Who cannot join
- psychiatric, neurological diseases
- uncorrected hearing or vision deficits
- actual psychopharmaco intake
- metal parts in the head
- medical electronical implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verbesserung Kognitiver Fähigkeiten im Alter
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probands which were randomized into verum or sham tDCS.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Verum tDCS, Sham tDCS
- Keywords
- Subjective Memory Impairment, tDCS, NIRS, Cognitive Training, Working Memory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum tDCSDevice
Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anodal, right cathodal
Sham tDCSDevice
Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
| Study group | Role | What they receive |
|---|---|---|
| Verum tDCS | Experimental | Left frontal anodal stimulation, supraorbital right cathodal stimulation Receives: Device: Verum tDCS |
| Sham tDCS | Experimental | sham stimulation, same electrode positions Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT)
The Investigators are measuring cognitive performance for different executive functions, here the score (percentile of the norm values) of the test verbal learning memory test (VLMT), parameter immediate recall post treatment is reported. Rage from 0 to 100 %. Higher values indicate higher performance.
Measured: 4 weeks
Secondary outcomes (1)
Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT)
NIRS is a brain imaging method, with the parameters of oxy (OxyHB) and deoxy (deoxyHB) hemoglobin. Activation is reflected by increase of OxyHB and decrease DeoxyHB. Differences from pre- to post-measurement for OxyHB are reported in a region of interest analysis of the dorsolateral prefrontal cortex.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin J. Herrmann, PD Dr, Principal investigator, University of Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587338
- Sponsor's protocol ID
- Wuerzburg22/15
- Acronym
- CATS
- Status last verified
- Mar 2024
- First submitted
- 16 Jun 2015
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verbesserung Kognitiver Fähigkeiten im Alter
- ClinicalTrials.gov ID
- NCT02587338
- Acronym / sponsor ID
- CATS / Wuerzburg22/15
- Conditions
- Mild Cognitive Impairment
- Keywords
- Subjective Memory Impairment, tDCS, NIRS, Cognitive Training, Working Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probands which were randomized into verum or sham tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum tDCS | Experimental | Device: Verum tDCSLeft frontal anodal stimulation, supraorbital right cathodal stimulation |
| Sham tDCS | Experimental | Device: Sham tDCSsham stimulation, same electrode positions |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- native german speaker
- between 60-70 years old
- subjective memory impairment
Key exclusion criteria (5 listed)
- psychiatric, neurological diseases
- uncorrected hearing or vision deficits
- actual psychopharmaco intake
- metal parts in the head
- medical electronical implants
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 |
|---|---|---|
| Verum tDCSNeuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anodal, right cathodal | Device | Verum tDCS |
| Sham tDCSNeuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere | Device | Sham tDCS |
Primary outcome
Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT)
Time frame: 4 weeks
The Investigators are measuring cognitive performance for different executive functions, here the score (percentile of the norm values) of the test verbal learning memory test (VLMT), parameter immediate recall post treatment is reported. Rage from 0 to 100 %. Higher values indicate higher performance.
1 secondary outcome
Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Martin J. Herrmann, PD Dr principal investigator
University of Würzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum tDCS in people with Mild Cognitive Impairment, run by Wuerzburg University Hospital 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 3 inclusion and 5 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 12 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neuropsychological Performance in Neuropsychological Test: Verbal Learning Memory Test (VLMT) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.