Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS

Mild Cognitive Impairment (MCI) Clinical Trial

Official title:

Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110043
• Other study ID #: LOCATO-MCI-tDCS
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: October 2017

Study information

• Verified date: May 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria (MCI patients):

• right handedness
• amnestic and amnestic plus MCI with:

1. subjective memory impairment;

2. objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values;

3. relatively normal performance in other cognitive domains;

4. no constraints in activities of daily livings

5. age: 50-90 years

Exclusion Criteria:

• severe internal or psychiatric disease
• epilepsy
• other severe neurological diseases, e.g. previous major stroke or brain tumor
• DMS-IV manifest dementia
• contraindication for MRT (claustrophobia, metallic implants, tattoos)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment (MCI)

Intervention

Device:
• tDCS
transcranial direct current stimulation (tDCS)

Behavioral:
• training
intensive training of visual-spatial abilities (in LOCATO task)

Locations

Country	Name	City	State
Germany	Charite Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Külzow N, Kerti L, Witte VA, Kopp U, Breitenstein C, Flöel A. An object location memory paradigm for older adults with and without mild cognitive impairment. J Neurosci Methods. 2014 Nov 30;237:16-25. doi: 10.1016/j.jneumeth.2014.08.020. Epub 2014 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS	Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.	immediately after end of a 3-day period of training in tDCS condition vs sham condition
Secondary	long term effects	long term effects measured by performance in LOCATO task in tDCS condition after end of cognitve training and after 1 month compared to control conditions	after 1 month vs baseline
Secondary	functional changes: Connectivity	Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training	end of 3-day cognitive training vs baseline
Secondary	cortical excitability	cortical excitability measured by transcranial magnetic stimulation (TMS)	at baseline
Secondary	Quality of Life	quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)	after 1 month vs baseline
Secondary	memory	memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation	immediately after end of 3-day of cognitive training, after 1 month vs. baseline
Secondary	affective state	affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation	immediately after the end of 3-day cognitive training, after 1 month vs. baseline
Secondary	genotyping of learning related polymorphisms	To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).	once