Transcranial Direct Current Stimulation in Major Depression

NCT03556124 | Completed

• 2 other identifiers: 17-000779R61MH110526
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms. We will investigate these questions in a two-part randomized double blind exploratory clinical trial. The first part of the trial will compare how current flow and functional imaging signal differs in the brain when using tDCS with more focal stimulation, called high definition (HD) tDCS, compared to conventional tDCS (C-tDCS) or sham (non-active) tDCS in patients with MDD. Sixty people with depression (20 in each group) will be randomized to receive either HD-tDCS, C-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham tDCS in the MRI scanner, which will allow us to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests

Conditions

Major Depressive Disorder

Keywords

Transcranial direct current stimulation; major depression; MRI

Outcome Measures

Primary Outcomes (2)

• Changes in non-invasive MRI measures of cerebral blood flow between baseline and end of treatment

  Modulation of the left dorsolateral prefrontal cortex (DLPFC) and dorsal anterior cingulate cortex (dACC) measured by percent rCBF signal change

  Up to 3 weeks

• Change in non-invasive MRI measures of current flow

  tDCS-induced in vivo magnetic field changes in the left DLPFC as the current is being ramped up from 0 to 2 mA in increments of 0.5 mA over the course of a 1-hour MRI scan

  1 hour

Study Arms (4)

Active - HD tDCS

EXPERIMENTAL

Participants randomized to this arm will receive 12 sessions of high definition tDCS (HD-tDCS) stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes.

Device: Active - HD tDCS

Active - Conventional tDCS

EXPERIMENTAL

Participants randomized to this arm will receive 12 sessions of conventional tDCS (C-tDCS) stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes.

Device: Active - Conventional tDCS

Sham - HD tDCS

SHAM COMPARATOR

Participants randomized to this arm will receive 12 sessions of sham HD tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes.

Device: Sham - HD tDCS

Sham - Conventional tDCS

SHAM COMPARATOR

Participants randomized to this arm will receive 12 sessions of sham conventional tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex for 20-30 minutes.

Device: Sham - Conventional tDCS

Interventions

Active - HD tDCS DEVICE

Non-invasive neuromodulation using HD electrodes placed on the scalp to deliver a constant, low current at 2 mA.

Active - HD tDCS

Sham - HD tDCS DEVICE

Sham neuromodulation using HD electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.

Sham - HD tDCS

Active - Conventional tDCS DEVICE

Non-invasive neuromodulation using standard 7 cm x 5 cm electrodes placed on the scalp to deliver a constant, low current at 2 mA.

Active - Conventional tDCS

Sham - Conventional tDCS DEVICE

Sham neuromodulation using standard 7 cm x 5 cm electrodes electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.

Sham - Conventional tDCS

Eligibility Criteria

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

You may qualify if:

• Age between 18 to 55 years, inclusive
• Gender: all
• Race/ethnicity: all races and ethnic groups
• Capacity to provide informed consent
• Hamilton Rating Scale for Depression (HAMD) score of ≥14 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
• Live within traveling distance to the University of California, Los Angeles (UCLA)

You may not qualify if:

• Pregnancy
• Non-English speaking
• Current Substance Use Disorder
• 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 MRI scanning (metal implants, claustrophobia or a breathing or movement disorder)
• Currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy
• 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, transcranial magnetic stimulation (rTMS), 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 including sleeping aids previously shown to interfere with cortical excitability
• Schizophrenia Axis I disorder
• Dementia of any type
• Bipolar I disorder

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

Location

Related Publications (2)

• Jog MA, Anderson C, Kubicki A, Boucher M, Leaver A, Hellemann G, Iacoboni M, Woods R, Narr K. Transcranial direct current stimulation (tDCS) in depression induces structural plasticity. Sci Rep. 2023 Feb 17;13(1):2841. doi: 10.1038/s41598-023-29792-6.

  PMID: 36801903 DERIVED

• Jog M, Anderson C, Kim E, Garrett A, Kubicki A, Gonzalez S, Jann K, Iacoboni M, Woods R, Wang DJ, Narr KL. A novel technique for accurate electrode placement over cortical targets for transcranial electrical stimulation (tES) clinical trials. J Neural Eng. 2021 Oct 11;18(5):10.1088/1741-2552/ac297d. doi: 10.1088/1741-2552/ac297d.

  PMID: 34555822 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Katherine Narr, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Active and Sham controlled

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: June 14, 2018
• Study Start: February 2, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)