NCT04031547

Brief Summary

This is a functional MRI study that will examine the effects of noninvasive transcranial electrical stimulation (tES) on brain function in individuals with Major Depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for early_phase_1 depression

Timeline
Completed

Started Feb 2019

Typical duration for early_phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

3.8 years

First QC Date

July 22, 2019

Last Update Submit

February 8, 2023

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Changes in brain function measured with blood-oxygenation-level-dependent (BOLD) functional MRI

    Blood-oxygenation-level-dependent functional MRI will be used to measure changes in the temporal coherence (functional connectivity) amongst brain regions before, during, and after tES.

    5 minutes before, 5 minutes during, and 5 minutes after tES

Study Arms (2)

Active tES-fMRI

ACTIVE COMPARATOR
Device: Transcranial Electrical Stimulation (tES)

Inactive/Sham tES-fMRI

SHAM COMPARATOR
Device: Transcranial Electrical Stimulation (tES)

Interventions

Transcranial Electrical Stimulation (tES)DEVICE

In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.

Also known as: Transcranial Direct Current Stimulation (tDCS)
Active tES-fMRIInactive/Sham tES-fMRI

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages between 18 and 55
  • diagnosis of Major Depressive Disorder made by a physician, psychiatrist, or psychologist at least one year prior
  • mild-to-moderate symptoms of depression (Hamilton Depression Rating Scale 17-item, HDRS-17, score 8-23)
  • stable standard or no pharmacological antidepressant regimen (SSRI, SNRI, MAOI, or trycyclic/TCA) with no change in treatment 6 weeks prior to study start

You may not qualify if:

  • suicidal thoughts, ideation, or behavior within the past month (HDRS-17 item 3 score greater than 1)
  • greater than moderate symptoms of depression within the past month (HDRS-17 score \>23)
  • change in antidepressant medication within 6 weeks of study start
  • diagnosis of any medical condition potentially affecting brain function, including neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, anxiety, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence
  • 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
  • other major medical conditions (e.g., cancer, stroke)
  • current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants
  • prisoners will not participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Translational Imaging at Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Amber Leaver, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 24, 2019

Study Start

February 1, 2019

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

US(1)