NCT02999607

Brief Summary

With this study we will be able to dose-dependently measure real-time glucose metabolism changes after non-invasively stimulating superficial parts of the dlPFC, a commonly used target in therapeutic tDCS applications. This will provide further insight if and how tDCS is capable to change one of most reliable parameters of brain metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable depression

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

December 18, 2016

Last Update Submit

January 12, 2018

Conditions

Keywords

Transcranial direct current stimulationPositron emission tomography

Outcome Measures

Primary Outcomes (1)

  • FDG-rCMRglu

    regional cerebral metabolic rate of glucose

    70 minutes

Study Arms (2)

active transcranial direct current stimulation

EXPERIMENTAL

Stimulation at three different intensities during FDG-PET scan

Other: transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Comparator to active arm

Other: transcranial direct current stimulation

Interventions

0.5 mA, 1mA, 2mA for 10 minutes each

Sham tDCSactive transcranial direct current stimulation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy controls:
  • \- Aged 18 to 55 years Somatic and psychiatric health based on medical history, physical examination, ECG, laboratory screening, SCID-I and II Willingness and competence to complete the informed consent process
  • Depressed Patients:
  • Current major depressive episode during unipolar major depression (MD) according to SCID-I (with HAMD\>17) No other concomitant axis-I disease apart from anxiety disorder, which must be secondary to MD Standard antidepressant medication stable during the last 4 weeks

You may not qualify if:

  • Concomitant major medical or neurological illness, including history of seizures Any current substance abuse disorder according to DSM-V (urinary test and history) including current sedative usage in MDD patients ECT, TMS or NMDA-antagonists (ketamine) during the past 6 months. Current augmentation with anti-epileptics, or other drugs affecting seizure threshold Failure to comply with the study protocol or follow the instructions of the investigators Pregnancy Participants with previous total radiation exposure dose of 30mSv over the last 10 years (according to legislation on radiation protection).
  • Left-handedness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv.-Doz.

Study Record Dates

First Submitted

December 18, 2016

First Posted

December 21, 2016

Study Start

December 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations