Evaluating tDCS Brain-stimulation in Depression Using MRI

NCT05598034 | Recruiting

• 2 other identifiers: MH128572K99MH128572
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Patients, physicians, and those who fund depression research are keenly interested in depression treatments that do not involve taking medications. One promising candidate treatment is transcranial direct current stimulation (tDCS), a low-cost technique that involves placing electrodes on specific scalp locations and using a 9-volt battery to cause a small amount of electricity to pass through parts of the brain. Depending on the direction of electrical flow, tDCS can make brain cells (neurons) more likely or less likely to generate their own electrical signals. When evaluated as a treatment, tDCS is typically done in daily sessions over a period of two weeks. One of the challenges of tDCS is to work out the best possible positioning of electrodes and direction of electricity flow to gradually cause lasting changes in brain activity in ways that might be expected to improve depression. To address this challenge, the investigators are using MRI to take pictures of the brain during tDCS. This data will help us better understand the short-term effects of tDCS in depression and help us learn how to customize future treatments to cause a lasting beneficial response. Patients with depression between the ages of 20-55 years are eligible to take part in this research. Potential participants will undergo:

1. 1.An assessment to confirm eligibility. This will take place over a secure videoconference call lasting no more than 3 hours.
2. 2.Two in-person study visits lasting 30 min and 2-1/2 hours respectively. In the first visit, the investigators will use the MRI to take a picture of the brain and head structure to determine appropriate locations for placing the tDCS electrodes at the start of the second visit. Following electrode placement, an MRI scan will be performed to take pictures of the brain during tDCS. Depending on the study arm,
3. 3.Participants may receive 'active' or 'sham' tDCS. The 'sham' condition is identical to the 'active' tDCS in every way except that it involves minimal tDCS and is designed to help rule out effects unrelated to the administered tDCS electricity.
4. 4.Participants may also be asked to perform a mental task during MRI.

Conditions

Major Depressive Disorder

Keywords

Transcranial Direct Current Stimulation (tDCS); MRI; Major Depression

Outcome Measures

Primary Outcomes (1)

• Activity changes in the dorso-fronto-limbic brain network

  fMRI-BOLD signal within nodes of the dorso-fronto-limbic brain network will be analyzed for activity changes concurrent with tDCS

  Within the 2.5 hour fMRI session

Secondary Outcomes (1)

• Connectivity changes in the dorso-fronto-limbic brain network

  Within the 2.5 hour fMRI session

Study Arms (4)

Left DLPFC tDCS

EXPERIMENTAL

Participants randomized to this arm will receive tDCS at the left DLPFC brain region.

Device: Left DLPFC tDCS

Left DLPFC tDCS + task

EXPERIMENTAL

Participants randomized to this arm will receive tDCS at the left DLPFC brain region. Additionally, participants will be asked to perform a mental task (2-back working memory) at the same time.

Device: Left DLPFC tDCS; Behavioral: Cognitive task

Right DLPFC tDCS

EXPERIMENTAL

Participants randomized to this arm will receive tDCS at the right DLPFC brain region.

Device: Right DLPFC tDCS

Right DLPFC tDCS + task

EXPERIMENTAL

Participants randomized to this arm will receive tDCS at the right DLPFC brain region. Additionally, participants will be asked to perform a mental task (2-back working memory) at the same time.

Device: Right DLPFC tDCS; Behavioral: Cognitive task

Interventions

Left DLPFC tDCS DEVICE

This intervention involves placing non-invasive scalp-electrodes over the left DLPFC brain region to deliver a mild, tolerable electric current.

Left DLPFC tDCS; Left DLPFC tDCS + task

Right DLPFC tDCS DEVICE

This intervention involves placing non-invasive scalp-electrodes over the right DLPFC brain region to deliver a mild, tolerable electric current.

Right DLPFC tDCS; Right DLPFC tDCS + task

Cognitive task BEHAVIORAL

Participants will be asked to perform a 2-back working memory mental task alongside administered tDCS

Left DLPFC tDCS + task; Right DLPFC tDCS + task

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 to 55 years, inclusive
• Gender: all
• Race/ethnicity: all races and ethnic groups
• Capacity to provide informed consent
• Hamilton Rating Scale for Depression score of ≥17 and \<24, with or without symptoms of anxiety.
• Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic's (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention.
• Work at UCLA or live within 1-hr driving distance of UCLA

You may not qualify if:

• Pregnancy
• Non-English speaking (due to scales administered)
• Substance Use Disorder within last 12 months
• Neurological condition associated with brain abnormalities (e.g., traumatic brain injury; recent stroke, tumor)
• Any contraindication to tDCS (e.g., skin disease or treatment causing irritation)
• Any condition that would contraindicate scanning (metal implants, claustrophobia or a breathing or movement disorder)
• Currently receiving any form of psychotherapy
• Change in antidepressant medication within 6-weeks of starting the trial
• Severe or treatment resistant depression - HAMD scores \> 24 and a history of a major depressive episode lasting \>2- years or failure to 2 or more antidepressant trials in the current index episode
• Any neuromodulation therapy (e.g., ECT, rTMS, DBS, VNS or tDCS) within the last 3-months
• Current or past (within the last 1-month) use of anticonvulsants, lithium, psychostimulant, dexamphetamine
• Current use of decongestants or other medication previously shown to interfere with cortical excitability
• Diagnosis: Schizophrenia Axis I disorder, or dementia of any type
• Bipolar I disorder (due to possible risk of mania and because lithium and anticonvulsants are excluded).
• On regular benzodiazepine medication that it is not clinically appropriate to discontinue for the 2-week duration of the trial

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Mayank A Jog, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayank A Jog, PhD

CONTACT

424-288-6483; brainmapping.ucla@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 28, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)