Modulating Default Mode Network Function: A Transcranial Direct Current Stimulation (TDCS) Pilot Study

NCT04598152 | Terminated Results FDA Device

• 1 other identifier: STUDY19090112
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this research is to gather scientific information about how different people's brains work when they look at different types of pictures. This will help to improve the investigators' understanding of the way the brain works for people who are depressed or anxious, and this knowledge could help lead to better diagnosis and treatment.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning.

  The investigators will determine the effects of TDCS on BOLD response in the precuneus/posterior cingulate gyrus. The BOLD signal is a measure of regional blood flow in the brain and is used as a proxy for neural activity in specific brain regions. Values below represent pre-post change in BOLD response to the emotion regulation task that participants complete during fMRI scanning. We hypothesize that tDCS applied to the target used in this study will decrease BOLD signal (lower values) during critical components of this task, normalizing function in this region.

  1 week (between baseline and repeat scanning)

Secondary Outcomes (1)

• The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition

  30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days

Study Arms (1)

Transcranial Direct Current Stimulation during fMRI

EXPERIMENTAL

Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner.

Device: TDCS - transcranial direct current stimulation

Interventions

TDCS - transcranial direct current stimulation DEVICE

TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.

Transcranial Direct Current Stimulation during fMRI

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18-30years old
• Score \> 10 on the QIDS or \> 60 on the PROMIS-A
• We will use a flexible extreme groups recruitment strategy to ensure an adequate distribution of ESC scores. We will ensure that at least 62% of the sample will be composed of those scoring .5 SD above or below the mean, as measured by the NEO-PI-R. This value corresponds to the expected values assuming a normal distribution of the trait.
• Normal or corrected to normal vision with contact lenses
• Able to provide informed consent in English
• Right-handed (Annett criteria)

You may not qualify if:

• Have a history of head trauma with loss of consciousness.
• Have a systemic medical illness that may impact fMRI measures of cerebral blood flow.
• Are pregnant (self report and tested for as part of any scan by the scanning center and not this protocol)
• Not native English speaking or not fluent
• Premorbid NAART IQ estimate\<85;
• Visual disturbance (worse than 20/40 Snellen visual acuity) that is not corrected
• If have visual disturbance, only access to correction with glasses (i.e., no access to contact lenses).
• Left/mixed handedness (Annett criteria), to ensure a uniform hemispheric dominance for interpretation of neuroimaging data
• Active suicidal ideation in need of immediate treatment
• Scoring below the cutoffs on both the QIDS and the PROMIS-A
• History of alcohol/substance use disorder (including nicotine) and/or illicit substance use (except cannabis) over the last 3 months, determined by the MINI. Lifetime/present cannabis use (non-disordered levels) will be allowed, given its common usage in individuals in this age range.
• Current or past psychotic-spectrum disorder
• History of seizures

Sponsors & Collaborators

• Jay Fournier: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

This study was closed due to Covid 19 restrictions. Only 3 people completed the protocol. No conclusions should be drawn from the results reported. Because of the low sample size, no statistical analyses were undertaken.

Results Point of Contact

• Title: Jay Fournier, PhD
• Organization: The Ohio State University College of Medicine

jay.fournier@osumc.edu

614-293-9600

Study Officials

• Jay C Fournier, Ph. D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: The first part of the study consists of screening procedures that are meant to determine if potential participants are eligible to take part in the remainder of the study. If you qualify to take part in the scanning portion of the study, you will have 2 scanning sessions on separate days approximately a week apart. For each scan session you will undergo a functional Magnetic Resonance Imaging (fMRI) scan that lasts approximately 30 minutes and no more than 1 hour. The total time you will spend for each scan session will be between 1-3 hours. During the scanning session you will receive transcranial direct current stimulation (tDCS). Prior to scanning, sponge-electrodes will be placed on your scalp. These electrodes will be connected to a stimulator. This stimulator will apply weak currents to the brain while the MRI takes pictures of your brain's responses. The stimulation current that you will experience is usually less than a 6-volt battery but may be increased up to 15-volts.

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 22, 2020
• Study Start: October 1, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: January 4, 2022
• Results First Posted: January 4, 2022

Record last verified: 2021-12

Locations

US (1)