Cognitive Ability Training for Seniors With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— MICE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02940457
• Other study ID #: Wuerzburg165/16
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Verum tDCS
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA
• Sham tDCS
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA

Locations

Country	Name	City	State
Germany	University Hospital	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activation measured with NIRS	The Investigators are measuring brain activation during executive functions	4 weeks
Primary	Reaction times, errors and number of generated words in neuropsychological tasks	The Investigators are measuring cognitive performance for different executive functions	4 weeks
Secondary	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
Secondary	Blood sampling	Increased BDNF secretion in serum	4 weeks