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

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• Status: Withdrawn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: Mild Cognitive Impairment
• Intervention / Treatment: Device: Verum tDCS; Device: 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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, 97080
    • University Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
T1 weighted magnetic resonance Imaging (MRI) of the brain	Structural changes in grey matter of the brain calculated by voxel based morphometry (VBM)	4 weeks
Blood sampling	Increased BDNF secretion in serum	4 weeks

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Principal Investigator: Martin Herrmann, Wuerzburg University Hospital

Study record dates

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: tDCS; MCI; fNIRS; Working Memory
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• 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