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

NCT ID: NCT04598152

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-03-09

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.

Detailed Description

In this study the investigators are examining the effects of weak electrical stimulation on brain activity as measured by functional magnetic resonance imaging (fMRI). MRI is a widely used method to obtain high resolution brain pictures that are routinely used for diagnostic and clinical purposes. The electrical stimulation is applied on the scalp with a non-FDA approved method called tDCS (transcranial Direct Current Stimulation), typically equivalent to what a 6V battery would produce (and up to no more than 15V). To compare, an AA battery delivers current at 1.5 volt. While almost unnoticeable to the participants, these currents can still temporarily affect brain activity without causing adverse effects. This stimulation would be applied while the participants are in the MRI scanner so that the brain activity can be measured. The participants will have the opportunity to have a test session with the stimulation outside the scanner to get familiar with it.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Transcranial Direct Current Stimulation during fMRI

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

Group Type: EXPERIMENTAL

TDCS - transcranial direct current stimulation

Intervention Type: 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.

Interventions

TDCS - transcranial direct current stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Between 18-30years old

2. Score > 10 on the QIDS or > 60 on the PROMIS-A

3. 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.

4. Normal or corrected to normal vision with contact lenses

5. Able to provide informed consent in English

6. Right-handed (Annett criteria)

Exclusion Criteria

1. Have a history of head trauma with loss of consciousness.

2. Have a systemic medical illness that may impact fMRI measures of cerebral blood flow.

4. Are pregnant (self report and tested for as part of any scan by the scanning center and not this protocol)

5. Not native English speaking or not fluent

6. Premorbid NAART IQ estimate<85;

7. Visual disturbance (worse than 20/40 Snellen visual acuity) that is not corrected

8. If have visual disturbance, only access to correction with glasses (i.e., no access to contact lenses).

9. Left/mixed handedness (Annett criteria), to ensure a uniform hemispheric dominance for interpretation of neuroimaging data

10. Active suicidal ideation in need of immediate treatment

11. Scoring below the cutoffs on both the QIDS and the PROMIS-A

12. 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.

13. Current or past psychotic-spectrum disorder

14. History of seizures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jay Fournier

OTHER

Sponsor Role: lead

Responsible Party

Jay Fournier

Assistant Professor of Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jay C Fournier, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY19090112

Identifier Type: -

Identifier Source: org_study_id