NCT02794259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

April 5, 2016

Last Update Submit

January 5, 2017

Conditions

Healthy Older Adults

Keywords

GABA concentrationtDCS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels

    assessed immediately before and after a 15-min stimulation time

  • Resting-state functional connectivity changes

    assessed during a 15-min stimulation time

  • Genotyping of learning related polymorphisms

    assessed during baseline screening

Study Arms (3)

Anodal tDCS

EXPERIMENTAL

Anodal stimulation during resting state fMRI

Device: tDCS

Cathodal tDCS

EXPERIMENTAL

Cathodal stimulation during resting state fMRI

Device: tDCS

Sham tDCS

SHAM COMPARATOR

Sham stimulation during resting state fMRI

Device: sham-tDCS

Interventions

tDCSDEVICE
Anodal tDCSCathodal tDCS
sham-tDCSDEVICE
Sham tDCS

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • unobtrusive neuropsychological screening
  • age: older adults of retirement age: ≥66 years

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (3)

  • 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.

    PMID: 24668166BACKGROUND

  • 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.

    PMID: 26381352BACKGROUND

  • 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.

    PMID: 26279408BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Flöel, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

April 5, 2016

First Posted

June 9, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

DE(1)