Brain Glucose Metabolism During Transcranial Direct Current Stimulation

NCT ID: NCT02999607

Last Updated: 2018-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

active transcranial direct current stimulation

Stimulation at three different intensities during FDG-PET scan

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type OTHER

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

Sham tDCS

Comparator to active arm

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transcranial direct current stimulation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rupert Lanzenberger

Assoc. Prof. Priv.-Doz.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3.0.30.11.16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.