Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT02110056
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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 of learning and memory in healthy older adults and to examine the underlying neuronal mechanism.

Condition or Disease	Intervention/Treatment	Phase
Healthy Older Adults	Device: tDCS; Behavioral: training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Modulation of Visual-Spatial Learning in Healthy Older Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: training + tDCS Combination of intensive training of visual-spatial abilities (LOCATO task) with transcranial direct current stimulation (tDCS)	Device: tDCS; transcranial direct current stimulation (tDCS); Behavioral: training; intensive training of visual-spatial abilities (in LOCATO task)
Sham Comparator: training + sham stimulation Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation	Device: tDCS; transcranial direct current stimulation (tDCS); Behavioral: training; intensive training of visual-spatial abilities (in LOCATO task)

Outcome Measures

Primary Outcome Measures

1. Performance in LOCATO task (Visual-Spatial learning and memory) after a combination of intensive visual-spatial training and tDCS [immediately after the end of a 3 day training period in tDCS condition compared to sham condition]

   Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to an improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day training period compared to sham stimulation.

Secondary Outcome Measures

1. long term effects [after 1 month vs baseline]

   long term effects measured by performance in LOCATO task after end of training and after 1 month compared to control condition

2. functional changes: Connectivity [after end of 3-day period of training vs baseline]

   Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training

3. cortical excitability [at baseline]

   measured by transcranial magnetic stimulation (TMS) at baseline

4. Quality of life [after 1 month vs baseline]

   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)

5. memory [immediately after end of 3-day of cognitive training, after 1 month vs. baseline]

   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

6. affective state [immediately after the end of 3-day cognitive training, after 1 month vs. baseline]

   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

7. genotyping of learning related polymorphisms [once]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria (old healthy controls):

• right handedness

• unobtrusive neuropsychological screening

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT02110056
• Other Study ID Numbers: LOCATO-OA-tDCS
• First Posted: Apr 10, 2014
• Last Update Posted: Jan 30, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany: healthy older adults; tDCS; LOCATO task; visual-spatial learning

Study Results

No Results Posted as of Jan 30, 2018