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Clinical Trials/NCT02940457
NCT02940457
Withdrawn
N/A

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

Wuerzburg University Hospital1 site in 1 countryNovember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Wuerzburg University Hospital
Locations
1
Primary Endpoint
Reaction times, errors and number of generated words in neuropsychological tasks
Status
Withdrawn
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
December 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Reaction times, errors and number of generated words in neuropsychological tasks

Time Frame: 4 weeks

The Investigators are measuring cognitive performance for different executive functions

Brain activation measured with NIRS

Time Frame: 4 weeks

The Investigators are measuring brain activation during executive functions

Secondary Outcomes

  • T1 weighted magnetic resonance Imaging (MRI) of the brain(4 weeks)
  • Blood sampling(4 weeks)

Study Sites (1)

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