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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02794259
First Posted: June 9, 2016
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
  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 older people, compared to sham tDCS.

Condition Intervention
Healthy Older Adults Device: tDCS Device: sham-tDCS

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

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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: 24
Study Start Date: April 2016
Study Completion Date: August 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794259


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