MRI-Guided High-Definition Transcranial Direct Current Stimulation (tDCS) for Depression

NCT05090397 | Completed

• 1 other identifier: STU00213826
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with major depression measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Changes in brain functional connectivity

  Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z).

  Acute/immediate

Secondary Outcomes (2)

• Changes in depressive symptoms (Hamilton)

  1 week, 2 weeks, 1 month

• Changes in depressive symptoms (Beck)

  1 week, 2 weeks, 1 month

Study Arms (2)

Active

EXPERIMENTAL

Device: Transcranial Direct Current Stimulation

Sham

SHAM COMPARATOR

Device: Sham Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).

Active

Sham Transcranial Direct Current Stimulation DEVICE

Sham Transcranial Direct Current Stimulation

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Ages between 18 and 65
• \. Race/ethnicity: all races and ethnic groups
• \. Sex/Gender: all
• \. Capacity to provide informed consent
• \. Diagnosis of Major Depressive Disorder made by volunteer's physician at least one year prior (confirmed by patient self-report)
• \. Currently under the care of a clinician for depression (psychiatrist, psychologist, or other clinician)
• \. Currently experiencing symptoms of depression (Patient Health Questionnaire 9, PHQ9 \>4 at screening; Hamilton Depression Rating Scale 17-item, HDRS-17, score \>8 at Visit 1)
• \. Stable or no pharmacological antidepressant regimen (SSRI, SNRI, MOAI, or tricyclic/TCA) with no change in treatment 6 weeks prior to study start

You may not qualify if:

• \. Ages below 18 (neurobiology is quite different in children vs. adults)
• \. Ages above 65 (cortical excitability changes with age)
• \. Active suicidal thoughts, ideation, or behavior with plan within the past month (HDRS-17 item 3 score 3-4)
• \. Change in antidepressant medication within 6 weeks of study start
• \. Diagnosis of any medical condition potentially affecting brain function: neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, primary anxiety disorder, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence within past 12 months, chronic pain (current, or for more than one year within the past one year), other major medical conditions (e.g., cancer, stroke).
• \. MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
• \. tES contraindications: skin conditions or injuries on the scalp hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers (also contraindicated for MRI)
• \. Non-English speakers (due to written consent and questionnaires administered)
• \. Neurostimulation or neuromodulation treatment for any reason within the past 3 months
• \. Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics.
• \. Prisoners will not participate in this study.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

CTI Northwestern

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 22, 2021
• Study Start: July 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)