Cognitive Ability Training for Seniors With Mild Cognitive Impairment

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02940457

Acronym

MICE

Enrollment

Registered

2016-10-21

Start date

2017-11-01

Completion date

2020-12-31

Last updated

2020-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

tDCS, MCI, Working Memory, fNIRS

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).

Interventions

DEVICEVerum tDCS

Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA

DEVICESham tDCS

Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Brain activation measured with NIRS	4 weeks	The Investigators are measuring brain activation during executive functions
Reaction times, errors and number of generated words in neuropsychological tasks	4 weeks	The Investigators are measuring cognitive performance for different executive functions

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026