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

Primary Purpose

Mild Cognitive Impairment

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Verum tDCS
Sham tDCS
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring tDCS, MCI, Working Memory, fNIRS

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Verum tDCS

Sham tDCS

Arm Description

prefrontal anodal stimulation

sham stimulation, same electrode positions

Outcomes

Primary Outcome Measures

Brain activation measured with NIRS
The Investigators are measuring brain activation during executive functions
Reaction times, errors and number of generated words in neuropsychological tasks
The Investigators are measuring cognitive performance for different executive functions

Secondary Outcome Measures

T1 weighted magnetic resonance Imaging (MRI) of the brain
Structural changes in grey matter of the brain calculated by voxel based morphometry (VBM)
Blood sampling
Increased BDNF secretion in serum

Full Information

First Posted
October 11, 2016
Last Updated
May 20, 2020
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02940457
Brief Title
Cognitive Ability Training for Seniors With Mild Cognitive Impairment
Acronym
MICE
Official Title
Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
The employe for the study quit and a new grant proposal was not financed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
tDCS, MCI, Working Memory, fNIRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum tDCS
Arm Type
Experimental
Arm Description
prefrontal anodal stimulation
Arm Title
Sham tDCS
Arm Type
Experimental
Arm Description
sham stimulation, same electrode positions
Intervention Type
Device
Intervention Name(s)
Verum tDCS
Intervention Description
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA
Primary Outcome Measure Information:
Title
Brain activation measured with NIRS
Description
The Investigators are measuring brain activation during executive functions
Time Frame
4 weeks
Title
Reaction times, errors and number of generated words in neuropsychological tasks
Description
The Investigators are measuring cognitive performance for different executive functions
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
T1 weighted magnetic resonance Imaging (MRI) of the brain
Description
Structural changes in grey matter of the brain calculated by voxel based morphometry (VBM)
Time Frame
4 weeks
Title
Blood sampling
Description
Increased BDNF secretion in serum
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Herrmann
Organizational Affiliation
Wuerzburg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Ability Training for Seniors With Mild Cognitive Impairment

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