Clinical trial NCT02794272: tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults Of Working Age
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Older Adults
Keywords: GABA concentration
tDCS
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
First posted: 2016-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: GABA concentration assessed by magnetic resonance spectroscopy (MRS) before and after anodal tDCS adjusted for baseline levels
timeFrame: assessed immediately before and after a 15-min stimulation time
Secondary outcomes:
measure: GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels
timeFrame: assessed immediately before and after a 15-min stimulation time
measure: Resting-state functional connectivity changes
timeFrame: assessed during a 15-min stimulation time
measure: Genotyping of learning related polymorphisms
timeFrame: assessed during baseline screening
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.
citation: Amadi U, Allman C, Johansen-Berg H, Stagg CJ. The Homeostatic Interaction Between Anodal Transcranial Direct Current Stimulation and Motor Learning in Humans is Related to GABAA Activity. Brain Stimul. 2015 Sep-Oct;8(5):898-905. doi: 10.1016/j.brs.2015.04.010. Epub 2015 May 1.
citation: Stagg CJ, Bachtiar V, Amadi U, Gudberg CA, Ilie AS, Sampaio-Baptista C, O'Shea J, Woolrich M, Smith SM, Filippini N, Near J, Johansen-Berg H. Local GABA concentration is related to network-level resting functional connectivity. Elife. 2014 Mar 25;3:e01465. doi: 10.7554/eLife.01465.