Evaluating tDCS Brain-stimulation in Depression Using MRI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorUniversity of California, Los Angeles

About this trial

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. An assessment to confirm eligibility. This will take place over a secure videoconference call lasting no more than 3 hours. 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,

1. 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. 2. Participants may also be asked to perform a mental task during MRI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 20 to 55 years, inclusive

Gender: all

Race/ethnicity: all races and ethnic groups

Capacity to provide informed consent

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Cognitive task

    Behavioral

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

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: Left DLPFC tDCSExperimental treatment 1 intervention
Group B: Left DLPFC tDCS + taskExperimental treatment 2 interventions
Group C: Right DLPFC tDCSExperimental treatment 1 intervention
Group D: Right DLPFC tDCS + taskExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Within the 2.5 hour fMRI session

Secondary outcomes

1

Connectivity changes in the dorso-fronto-limbic brain network

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

Time frame
Within the 2.5 hour fMRI session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator