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Completed

NCT Number: NCT02794259

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

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.

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Key information

Conditions

Healthy Older Adults

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

tDCS

Device

sham-tDCS

Device

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)

Registry information

Official study title

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

Acronym: TRAINSTIM1

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2016
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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