Study Stopped
The employe for the study quit and a new grant proposal was not financed
Cognitive Ability Training for Seniors With Mild Cognitive Impairment
MICE
Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \[tDCS\]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 26, 2020
April 1, 2019
3.1 years
October 11, 2016
May 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Brain activation measured with NIRS
The Investigators are measuring brain activation during executive functions
4 weeks
Reaction times, errors and number of generated words in neuropsychological tasks
The Investigators are measuring cognitive performance for different executive functions
4 weeks
Secondary Outcomes (2)
T1 weighted magnetic resonance Imaging (MRI) of the brain
4 weeks
Blood sampling
4 weeks
Study Arms (2)
Verum tDCS
EXPERIMENTALprefrontal anodal stimulation
Sham tDCS
EXPERIMENTALsham stimulation, same electrode positions
Interventions
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA
Eligibility Criteria
You may qualify if:
- suspected MCI
- total CERAD score \<= 85.1
- MMSE \>=24
- native german speaker
- between 50-75 years old
- right handed
You may not qualify if:
- impairment of daily living activities
- psychiatric, neurological diseases
- uncorrected hearing or vision deficits
- actual psychopharmaca intake
- metal parts in the head
- medical electronical implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Würzburg, 97080, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Herrmann
Wuerzburg University Hospital
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
- SPONSOR
Study Record Dates
First Submitted
October 11, 2016
First Posted
October 21, 2016
Study Start
November 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
May 26, 2020
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share