Cognitive Ability Training for Seniors With Mild Cognitive Impairment

Not Applicable

Withdrawn

• Conditions: Mild Cognitive Impairment
• Interventions: Device: Verum tDCS; Device: Sham tDCS

• Registration Number: NCT02940457
• Lead Sponsor: Wuerzburg University Hospital

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).

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-21
• Study Start: 2017-11-01
• Status Verified: 2019-04
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-26
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum tDCS	Verum tDCS	prefrontal anodal stimulation
Sham tDCS	Sham tDCS	sham stimulation, same electrode positions

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Wuerzburg, Germany