Cognitive Ability Training for Seniors With Mild Cognitive Impairment

NCT ID: NCT02940457

Last Updated: 2020-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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).

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Verum tDCS

prefrontal anodal stimulation

Group Type EXPERIMENTAL

Verum tDCS

Intervention Type DEVICE

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

Sham tDCS

sham stimulation, same electrode positions

Group Type EXPERIMENTAL

Sham tDCS

Intervention Type DEVICE

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

Interventions

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Verum tDCS

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

Intervention Type DEVICE

Sham tDCS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Herrmann

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Locations

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University Hospital

Würzburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Wuerzburg165/16

Identifier Type: -

Identifier Source: org_study_id

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