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Cognitive Ability Training for Seniors With Mild Cognitive Impairment (MICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940457
Recruitment Status : Withdrawn (The employe for the study quit and a new grant proposal was not financed)
First Posted : October 21, 2016
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE October 21, 2016
Last Update Posted Date May 26, 2020
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Brain activation measured with NIRS [ Time Frame: 4 weeks ]
    The Investigators are measuring brain activation during executive functions
  • Reaction times, errors and number of generated words in neuropsychological tasks [ Time Frame: 4 weeks ]
    The Investigators are measuring cognitive performance for different executive functions
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • Brain activation measured with NIRS [ Time Frame: 4 weeks ]
  • Neuropsychological performance in neuropsychological tests [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • T1 weighted magnetic resonance Imaging (MRI) of the brain [ Time Frame: 4 weeks ]
    Structural changes in grey matter of the brain calculated by voxel based morphometry (VBM)
  • Blood sampling [ Time Frame: 4 weeks ]
    Increased BDNF secretion in serum
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Ability Training for Seniors With Mild Cognitive Impairment
Official Title  ICMJE Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung
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.
Detailed Description

In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment.

All test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • Device: Verum tDCS
    Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA
  • Device: Sham tDCS
    Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA
Study Arms  ICMJE
  • Experimental: Verum tDCS
    prefrontal anodal stimulation
    Intervention: Device: Verum tDCS
  • Experimental: Sham tDCS
    sham stimulation, same electrode positions
    Intervention: Device: Sham tDCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 20, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
50
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • suspected MCI
  • total CERAD score <= 85.1
  • MMSE >=24
  • native german speaker
  • between 50-75 years old
  • right handed

Exclusion Criteria:

  • impairment of daily living activities
  • psychiatric, neurological diseases
  • uncorrected hearing or vision deficits
  • actual psychopharmaca intake
  • metal parts in the head
  • medical electronical implants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02940457
Other Study ID Numbers  ICMJE Wuerzburg165/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wuerzburg University Hospital
Study Sponsor  ICMJE Wuerzburg University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Herrmann Wuerzburg University Hospital
PRS Account Wuerzburg University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP