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Completed

NCT Number: NCT02999607

Brain Glucose Metabolism During Transcranial Direct Current Stimulation

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

About this study

With this study, we will be able to substantiate if regional and whole brain glucose metabolism is affected by tDCS, assess the amount of signal change in relation to different currents and measure differences in glucose metabolism under stimulation reactivity between healthy subjects and depressive patients. The objective is to investigate the changes of regional cerebral metabolic rate of glucose (rCMRglu) in the brain after transcranial direct current stimulation in healthy subjects and depressive patients. The design is a cross-sectional proof of principle study in 20 healthy subjects and 20 depressed patients. During the PET scan tDCS will be applied with varying stimulus intensity. Furthermore, subjects will undergo a second PET scan with single-blind sham stimulation in order to validate the effects of tDCS. rCMRglu will be quantified using voxel-wise and ROI-based approaches. Changes in rCMRglu associated with tDCS-application will be calculated with a general linear model in a ramp function of the task-specific glucose uptake, according to previous work in our group. Exploratory statistical testing will be done using a paired samples t-test between task and rest conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

transcranial direct current stimulation

Other

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

Primary outcomes

  1. FDG-rCMRglu

    Time frame: 70 minutes

    regional cerebral metabolic rate of glucose

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Brain Glucose Metabolism in Healthy Subjects and Depressive Patients During Transcranial Direct Current Stimulation

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2016
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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