Brain Glucose Metabolism During Transcranial Direct Current Stimulation
Brain Glucose Metabolism in Healthy Subjects and Depressive Patients During Transcranial Direct Current Stimulation
1 other identifier
interventional
15
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Dec 2016
Shorter than P25 for not_applicable depression
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
December 18, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJanuary 16, 2018
January 1, 2018
9 months
December 18, 2016
January 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FDG-rCMRglu
regional cerebral metabolic rate of glucose
70 minutes
Study Arms (2)
active transcranial direct current stimulation
EXPERIMENTALStimulation at three different intensities during FDG-PET scan
Sham tDCS
SHAM COMPARATORComparator to active arm
Interventions
0.5 mA, 1mA, 2mA for 10 minutes each
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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