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

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.
 
ClinicalTrials.gov Identifier: NCT02794259
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE April 5, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date January 6, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults of Retirement Age
Official Title  ICMJE Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Older Adults
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Healthy Older Adults
Intervention  ICMJE
  • Device: tDCS
  • Device: sham-tDCS
Study Arms  ICMJE
  • Experimental: Anodal tDCS
    Anodal stimulation during resting state fMRI
    Intervention: Device: tDCS
  • Experimental: Cathodal tDCS
    Cathodal stimulation during resting state fMRI
    Intervention: Device: tDCS
  • Sham Comparator: Sham tDCS
    Sham stimulation during resting state fMRI
    Intervention: Device: sham-tDCS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 66 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794259
Other Study ID Numbers  ICMJE TRAINSTIM1.A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agnes Flöel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
Investigators  ICMJE
Principal Investigator: Agnes Flöel, Prof. Dr. Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP