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tDCS Effects on GABA Concentration and Brain Functional Connectivity in Young Adults (TRAINSTIM1)

This study has been completed.
Sponsor:
Collaborator:
Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02794298
First received: April 5, 2016
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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 younger people, compared to sham tDCS.

Condition Intervention
Healthy Young Adults
Device: Transcranial direct current stimulation (tDCS)
Device: sham-tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Young Adults.

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Measurement of GABA concentration 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 younger adults compared to sham stimulation.


Secondary Outcome Measures:
  • GABA concentration assessed by MRS 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.

  • 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

  • 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.


Enrollment: 32
Study Start Date: April 2016
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anodal tDCS
Anodal stimulation during resting state fMRI
Device: Transcranial direct current stimulation (tDCS)
Experimental: Cathodal tDCS
Cathodal stimulation during resting state fMRI
Device: Transcranial direct current stimulation (tDCS)
Sham Comparator: sham tDCS
Sham stimulation during resting state fMRI
Device: sham-tDCS

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • unobtrusive neuropsychological screening
  • age: young adults: 18-30 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02794298

Locations
Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
Investigators
Principal Investigator: Agnes Flöel, Prof. Dr. Charite University, Berlin, Germany