tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults of Retirement Age (TRAINSTIM1)

January 5, 2017 updated by: Agnes Flöel, Charite University, Berlin, Germany

Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Older Adults

The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in older people, compared to sham tDCS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Universitatsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unobtrusive neuropsychological screening
  • age: older adults of retirement age: ≥66 years

Exclusion Criteria:

  • Mild cognitive impairment (MCI) or other neurological diseases.
  • History of severe alcoholism or use of drugs.
  • Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
  • Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal tDCS
Anodal stimulation during resting state fMRI
Device: tDCS
Experimental: Cathodal tDCS
Cathodal stimulation during resting state fMRI
Device: tDCS
Sham Comparator: Sham tDCS
Sham stimulation during resting state fMRI
Device: sham-tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GABA concentration assessed by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels
Time Frame: assessed immediately before and after a 15-min stimulation time
Investigation whether anodal tDCS leads to a significant reduction of M1-GABA concentration in older adults compared to sham stimulation.
assessed immediately before and after a 15-min stimulation time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels
Time Frame: assessed immediately before and after a 15-min stimulation time
To assess stimulation effects on GABA concentration by magnetic resonance spectroscopy are measured before and after cathodal tDCS.
assessed immediately before and after a 15-min stimulation time
Resting-state functional connectivity changes
Time Frame: assessed during a 15-min stimulation time
Functional connectivity as measured by resting-state fMRI during tDCS compared to sham
assessed during a 15-min stimulation time
Genotyping of learning related polymorphisms
Time Frame: assessed during baseline screening
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed
assessed during baseline screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRAINSTIM1.A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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