- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02587338
Cognitive Ability Training in Seniors (CATS)
March 11, 2024 updated by: Wuerzburg University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Wuerzburg, Germany, 97080
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- native german speaker
- between 60-70 years old
- subjective memory impairment
Exclusion Criteria:
- psychiatric, neurological diseases
- uncorrected hearing or vision deficits
- actual psychopharmaco intake
- metal parts in the head
- medical electronical implants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Verum tDCS
Left frontal anodal stimulation, supraorbital right cathodal stimulation
|
Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anodal, right cathodal
|
|
Experimental: Sham tDCS
sham stimulation, same electrode positions
|
Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain Activation Measured With Near-infrared Spectroscopy (NIRS) During the Semantic Condition of the Verbal Fluency Task (VFT)
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin J. Herrmann, PD Dr, University of Würzburg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
June 16, 2015
First Submitted That Met QC Criteria
October 26, 2015
First Posted (Estimated)
October 27, 2015
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wuerzburg22/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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