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Clinical Trials/NCT02794272
NCT02794272CompletedNot Applicable

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

Charite University, Berlin, Germany1 site in 1 country24 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
GABA concentration assessed by magnetic resonance spectroscopy (MRS) before and after anodal tDCS adjusted for baseline levels

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •unobtrusive neuropsychological screening
  • •age: older adults of working age: 50-65 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).

Arms & Interventions

Cathodal tDCS

Experimental

Cathodal stimulation during resting state fMRI

Intervention: tDCS (Device)

Anodal tDCS

Experimental

Anodal stimulation during resting state fMRI

Intervention: tDCS (Device)

sham tDCS

Sham Comparator

Sham stimulation during resting state fMRI

Intervention: sham-tDCS (Device)

Outcomes

Primary Outcomes

GABA concentration assessed by magnetic resonance spectroscopy (MRS) before and 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

  • GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels(assessed immediately before and after a 15-min stimulation time)
  • Genotyping of learning related polymorphisms(assessed during baseline screening)
  • Resting-state functional connectivity changes(assessed during a 15-min stimulation time)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Agnes Flöel

Prof. Dr.

Charite University, Berlin, Germany

Study Sites (1)

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