Brain Glucose Metabolism During Transcranial Direct Current Stimulation

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999607
• Other study ID #: 3.0.30.11.16
• Status: Completed
• Phase: N/A
• First received: December 18, 2016
• Last updated: January 12, 2018
• Start date: December 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Other:
• transcranial direct current stimulation
0.5 mA, 1mA, 2mA for 10 minutes each

Locations

Country	Name	City	State
Austria	Department of Psychiatry and Psychotherapy, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FDG-rCMRglu	regional cerebral metabolic rate of glucose	70 minutes