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

Primary Purpose

Depression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation

Sham Transcranial Direct Current Stimulation

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Ages between 18 and 65
2. Race/ethnicity: all races and ethnic groups
3. Sex/Gender: all
4. Capacity to provide informed consent
5. Diagnosis of Major Depressive Disorder made by volunteer's physician at least one year prior (confirmed by patient self-report)
6. Currently under the care of a clinician for depression (psychiatrist, psychologist, or other clinician)
7. 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)
8. Stable or no pharmacological antidepressant regimen (SSRI, SNRI, MOAI, or tricyclic/TCA) with no change in treatment 6 weeks prior to study start

Exclusion Criteria:

1. Ages below 18 (neurobiology is quite different in children vs. adults)
2. Ages above 65 (cortical excitability changes with age)
3. Active suicidal thoughts, ideation, or behavior with plan within the past month (HDRS-17 item 3 score 3-4)
4. Change in antidepressant medication within 6 weeks of study start
5. 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).
6. MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
7. 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)
8. Non-English speakers (due to written consent and questionnaires administered)
9. Neurostimulation or neuromodulation treatment for any reason within the past 3 months
10. Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics.
11. Prisoners will not participate in this study.

Sites / Locations

CTI NorthwesternRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active

Sham

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Changes in depressive symptoms (Hamilton)

Symptoms of depression will be measured before and after 5 sessions of tDCS using Hamilton Depression Rating Scale (HDRS 17-item). Change HDRS score will be used as a secondary outcome measure. Score range is 0-53, where low scores indicate low symptoms.

Changes in depressive symptoms (Beck)

Symptoms of depression will be measured before and after 5 sessions of tDCS using Beck Depression Inventory (BDI). Change BDI score will be used as a secondary outcome measure. Score range is 0-62, where low scores indicate low symptoms.

Full Information

NCT ID

NCT05090397

First Posted

October 8, 2021

Last Updated

July 14, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT05090397

Brief Title

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

Official Title

Applied Strategies for MRI-Guided High-Definition tDCS for Major Depression

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2023 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is an investigator-initiated MRI research study of a noninvasive neurostimulation technique, transcranial direct current stimulation (tDCS) using focal "high definition" (HD) electrodes positioned using pre-treatment MRI. Primary objective is to measure changes in brain function during MRI-guided HDtDCS with MRI. Secondary objective is to measure changes in depressive symptoms after five consecutive days of MRI-guided tDCS (20 minutes per session).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Title

Sham

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham Transcranial Direct Current Stimulation

Intervention Description

Sham Transcranial Direct Current Stimulation

Primary Outcome Measure Information:

Title

Changes in brain functional connectivity

Description

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).

Time Frame

Acute/immediate

Secondary Outcome Measure Information:

Title

Changes in depressive symptoms (Hamilton)

Description

Time Frame

1 week, 2 weeks, 1 month

Title

Changes in depressive symptoms (Beck)

Description

Time Frame

1 week, 2 weeks, 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Ages between 18 and 65 2. Race/ethnicity: all races and ethnic groups 3. Sex/Gender: all 4. Capacity to provide informed consent 5. Diagnosis of Major Depressive Disorder made by volunteer's physician at least one year prior (confirmed by patient self-report) 6. Currently under the care of a clinician for depression (psychiatrist, psychologist, or other clinician) 7. 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) 8. Stable or no pharmacological antidepressant regimen (SSRI, SNRI, MOAI, or tricyclic/TCA) with no change in treatment 6 weeks prior to study start Exclusion Criteria: 1. Ages below 18 (neurobiology is quite different in children vs. adults) 2. Ages above 65 (cortical excitability changes with age) 3. Active suicidal thoughts, ideation, or behavior with plan within the past month (HDRS-17 item 3 score 3-4) 4. Change in antidepressant medication within 6 weeks of study start 5. 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). 6. MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy 7. 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) 8. Non-English speakers (due to written consent and questionnaires administered) 9. Neurostimulation or neuromodulation treatment for any reason within the past 3 months 10. Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics. 11. Prisoners will not participate in this study.

Facility Information:

Facility Name

CTI Northwestern

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amber Leaver

Phone

312-694-2966

amber.leaver@northwestern.edu

12. IPD Sharing Statement

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

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