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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Recruitment Status : Withdrawn (The employe for the study quit and a new grant proposal was not financed)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

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Verum tDCS Device: Sham tDCS Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Verum tDCS
prefrontal anodal stimulation
Device: Verum tDCS
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA

Experimental: Sham tDCS
sham stimulation, same electrode positions
Device: Sham tDCS
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA




Primary Outcome Measures :
  1. Brain activation measured with NIRS [ Time Frame: 4 weeks ]
    The Investigators are measuring brain activation during executive functions

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. Blood sampling [ Time Frame: 4 weeks ]
    Increased BDNF secretion in serum



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940457


Locations
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Germany
University Hospital
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Martin Herrmann Wuerzburg University Hospital
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT02940457    
Other Study ID Numbers: Wuerzburg165/16
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuerzburg University Hospital:
tDCS
MCI
Working Memory
fNIRS
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders