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

Healthy Older Adults Clinical Trial

— TRAINSTIM1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794259
• Other study ID #: TRAINSTIM1.A
• Status: Completed
• Phase: N/A
• First received: April 5, 2016
• Last updated: January 5, 2017
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 66 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Older Adults

Intervention

Device:
• tDCS

• sham-tDCS

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GABA concentration assessed by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels	Investigation whether anodal tDCS leads to a significant reduction of M1-GABA concentration in older adults compared to sham stimulation.	assessed immediately before and after a 15-min stimulation time	No
Secondary	GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels	To assess stimulation effects on GABA concentration by magnetic resonance spectroscopy are measured before and after cathodal tDCS.	assessed immediately before and after a 15-min stimulation time	No
Secondary	Resting-state functional connectivity changes	Functional connectivity as measured by resting-state fMRI during tDCS compared to sham	assessed during a 15-min stimulation time	No
Secondary	Genotyping of learning related polymorphisms	To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed	assessed during baseline screening	No