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

May 20, 2020 updated by: Wuerzburg University Hospital

Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

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

  • Germany
      • 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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activation measured with NIRS
Time Frame: 4 weeks
The Investigators are measuring brain activation during executive functions
4 weeks
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 weeks
Blood sampling
Time Frame: 4 weeks
Increased BDNF secretion in serum
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Investigators

  • Principal Investigator: Martin Herrmann, Wuerzburg University Hospital

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)

November 1, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 20, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wuerzburg165/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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